Predicate Devices

K102080, K001991, K011489, K013352, K023453, K030122, K202472, K210581, K192946

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a portfolio of hip implants and their materials/designs. There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis, treatment planning, or device function. The performance studies focus on MR safety, not algorithmic performance.

Therapeutic

Yes
The device is a hip implant, indicated for conditions like severe pain, disabled joints, and fractures, which directly alleviate or restore function for therapeutic purposes.

Diagnostic

No

Explanation: The document describes hip implants, which are prosthetic devices used for replacement, not for diagnosing conditions. The "Intended Use / Indications for Use" outlines conditions for which the hip replacement is indicated, not that the device itself performs a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the submission covers a portfolio of hip implants, which are physical hardware components (Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components). The testing described also relates to the physical properties of these implants in an MR environment.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use clearly describes the device as a total or hemi hip replacement for treating various conditions affecting the hip joint. This is a surgical intervention, not a diagnostic test performed on samples from the human body.
Device Description: The device is described as a portfolio of hip implants (stems, shells, liners, heads, components). These are physical implants designed to replace or augment parts of the hip joint.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is a therapeutic implant.

Therefore, this device falls under the category of a medical device (specifically, a prosthetic implant), but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Product codes

MEH, LPH, JDI, LWJ, LZO, KWL, KWY, LZY, HWC, LRN

Device Description

SUMMIT Product Family
The DePuy SUMMIT™ Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip stem is manufactured from Titanium (Ti6Al4V) and has a sintered commercially pure titanium bead porous coating (Porocoat) applied to the stem. The hip stem consists of 11 body sizes ranging in diameter from 6mm to 18mm with each body size having two offset options.
The DePuy SUMMIT™ DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti6Al4V) and has a sintered commercially pure Titanium bead porous coating (Porocoat) applied to the stem. The porous coating is applied over the circumferential ridges on the proximal region of the stem. The ridges effectively act as small internal collars and turn shear loading of the bone into compressive loading.
The SUMMIT™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.
The SUMMIT™ FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. The SUMMIT™ FX Cemented Hip Stem is offered in 7 sizes with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. The stem is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.
The SUMMIT™ Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.

ACTIS Product Family
The DePuy ACTIS™ DuoFix prostheses are manufactured from forged titanium alloy (TiçAl♪) and have a sintered commercially pure titanium bead porous coating (Porocoat) and a thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.
The ACTIS™ DuoFix Hip Prosthesis – Collarless is manufactured from the exact same materials to that of the collared prosthesis to meet the need of surgeons whose preference is to use a femoral stem without a collar for hip arthroplasty.

CORAIL Product Family
The DePuy CORAIL™ AMT hip stems are manufactured from forged titanium alloy (TiçAl૖V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stems consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail stems are available with or without a collar, with various neck angles, and with various neck offsets.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint, femoral head, femoral neck, acetabulum, proximal femur.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing is provided to support the conditional safety of the DePuy SUMMIT™, DePuy ACTIS™ Duofix, and DePuy CORAIL™ Hip Prosthesis in the MR environment, including assessment of;
Magnetically Induced Displacement Force (ASTM F2052-21)
Magnetically Induced Displacement Torque (ASTM F2213-17)
Radio Frequency (RF) Heating (ASTM F2182-19)
Image Artifacts (ASTM F2119-07)
The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K102080, K001991, K011489, K013352, K023453, K030122, K202472, K210581, K192946

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 19, 2024

DePuy Ireland UC % Jennifer Hill Regulatory Affairs Project Leader DePuy Synthes 3 Main Street Ringaskiddy, Loughbeg Ireland

Re: K231873

Trade/Device Name: DePuy SUMMIT Porocoat Hip Prosthesis - MR Conditional. DePuy SUMMIT DuoFix Hip Prosthesis - MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis - MR Conditional, DePuv SUMMIT FX Cemented Hip Prosthesis -MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis - MR Conditional Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LPH, JDI, LWJ, LZO, KWL, KWY, LZY, HWC, LRN Dated: December 14, 2023 Received: December 14, 2023

Dear Jennifer Hill:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

1

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

Sincerely,

Limin Sun S

Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

FDA IFU FORMS 3381

4

HIP STEMS FDA IFU FORMS 3381

5

510(k) Number (if known) K942370/K961619

Device Name ENDURANCE CEMENTED HIP PROSTHESIS, ENDURANCE CALCAR PROSTHESIS

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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6

510(k) Number (if known)

K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570

Device Name

C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOTA HIP SYSTEM, S-ROM TOTAL HIP SYSTEM, S-ROM COATED ZT PROXIMAL HIP SYSTEM, S-ROM FEMORAL HIP STEM, MODULAR CATHCART FRACTURE SYSTEM, TRI-LOCK BPS

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.

HA-coated stems of the CORAIL Hip System are indicated for cementless use only.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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7

510(k) Number (if known) K102080/K221462

Device Name RECLAIM MODULAR REVISION HIP SYSTEM, RECLAIM MONOBLOC REVISION HIP SYSTEM

Indications for Use (Describe)

The DePuy RECLAIM Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Type of Use (Select one or both, as applicable)
egative
Over-The-Counter Use (21 CFR 801 Subpart C)

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8

510(k) Number (if known) K953703/K030979/K060581

Device Name VISION SOLUTION HIP PROSTHESIS, SOLUTION SYSTEM HIP PROSTHESIS

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

The Solution Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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9

510(k) Number (if known)

K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946

Device Name

SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT HIP PROSTHESIS, ACTIS DUOFIX, ACTIS DUOFIX COLLARLESS HIP PROSTHESIS, EMPHASYS FEMORAL STEM, CORAIL AMT HIP PROSTHESIS

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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10

ACETABULAR PRODUCTS FDA IFU FORMS 3381

11

510(k) Number (if known) K203532

Device Name BI-MENTUM ALTRX DUAL MOBILITY LINERS

Indications for Use (Describe)

BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement in the following conditions:

1. Osteoarthritis
1. Femoral neck fracture
1. Dislocation risk
1. Osteonecrosis of the femoral head

Revision procedures where other treatments or devices have failed are if bone reconstruction so permits

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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12

510(k) Number (if known) K200854

Device Name PINNACLE DUAL MOBILITY LINER

Indications for Use (Describe)

Total hip replacement or hip arthroplasty is indicated in the following conditions:

A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
Failed previous hip surgery.
Dislocation risks.

PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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13

510(k) Number (if known)

K072963, K102423, K132959, K090998, K093646, K033273, K001534

Device Name

PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PINNACLE ACETABULAR ENHANCED STABILITY LINERS, PINNACLE ACETABULAR SYSTEM

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

14

510(k) Number (if known)

K03338. K192919. K040544. K951674. K961186. K994415. K010171. K863184. K221636

Device Name

PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, DURALOC 100C CUP, DURALOC CEMENTLESS CUP SYSTEM, MARATHON CROSS-LINKED POLYETHYLENE CUP LINERS, 36MM MARATHON LINERS, PROFILE ACETABULUM PROSTHESIS, EMPHASYS ACETABULAR SYSTEM

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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15

FEMORAL HEADS FDA IFU FORMS 3381

16

510(k) Number (if known)

K860701. K880269. K883460. K060031. K120599. K222296. K011533. K031803. K062748. K071830. K871867

Device Name

HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR M HEADS, 36mm FEMORAL HEADS, ARTICUL/EZE CERAMIC HEADS, DELTA CERAMIC FEMORAL HEADS, DELTA TS CERAMIC FEMORAL HEADS, ELITE FEMORAL HEADS

Indications for Use (Describe)

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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17

510(k) Number (if known) K812672

Device Name SELF-CENTERING HIP

Indications for Use (Describe)

Self-Centering hip arthroplasty is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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18

510(k) Number (if known) K851422/K920317

Device Name S-ROM FEMORAL HEADS

Indications for Use (Describe)

INDICATIONS - TOTAL HIP PROSTHESIS

Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.

1. Acute traumatic fracture of the femoral head or neck.

Certain cases of ankylosis.

INDICATIONS - HEMI-HIP PROSTHESIS

Hemi-hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.
1. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
1. Avascular necrosis of the femoral head.
1. Non-union of femoral neck fractures.
1. Certain high subcapital and femoral neck fractures in the elderly.
1. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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19

COMPONENTS FDA IFU FORMS 3381

20

510(k) Number (if known) K861979, K970929, K983014, K123924

Device Name

DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCREWS, GRIPTION TF 5.5mm LOCKING SCREWS

Indications for Use (Describe)

The DePuy Screws are indicated for use in primary or revision hip surgery for total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoir arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

21

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22

510(k) Number (if known) K963309

Device Name

DEPUY APEX HOLE ELIMINATOR PS

Indications for Use (Describe)

The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc series two-piece (metal shell and UHMWPe liner) acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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23

510(k) Number (if known) K971682

Device Name

DEPUY J-FX CERCLAGE SYSTEM

Indications for Use (Describe)

The I-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopaedic repairs. These include procedures such as: reinforcement of bone; reattachment of the greater trochanter; fixation of long bone fractures with grafting; and fixation of patellar fractures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---------------------------------------------

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24

510(k) Number (if known) K100391

Device Name

DEPUY GRIPTION TF CONES & HIP AUGMENTS

Indications for Use (Describe)

The DePuy Gription TF Acetabular Augments, Buttresses and Shims are in total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoir arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled porous titanium augment is intended for cemented or cementless use.

The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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26

510(k) Number (if known) K800894

Device Name

DEPUY CEMENT RESTRICTOR

Indications for Use (Describe)

The UHMWPe cement restrictor is intended for use in cemented total and hemiarthroplasty procedures to restrict distal flow of bone cement in the femoral medullary cavity.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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27

510(k) Number (if known) K871510

Device Name

DEPUY MODIFIED PROFILE HIP PMMA CEMENT SPACER

Indications for Use (Describe)

The Modified Profile Hip PMMA Spacer is indicated for use in cemented hip replacement.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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28

510(k) Number (if known) K963206, K951000

Device Name

DEPUY S-ROM HIP SYSTEM LOCKING PLUG, S-ROM SCREWS

Indications for Use (Describe)

Total hip arthroplasty is indicated for total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Type of Use (Select one or both, as applicable)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

29

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510k Summaries

31

HIP STEMS 510k Summaries

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	C-STEM™ System
C-STEM™ AMT Hip Prosthesis
CORAIL™ Revision Hip Prosthesis
S-ROM™ Femoral Total Hip System
S-ROM™ Total Hip System
S-ROM™ Coated ZT Proximal Hip System
S-ROM™ Femoral Hip Stem (Sizes 12x06x115 & 12x07x115)
Tri-Lock Bone Preservation Stem
Common or usual name	Total Hip Joint Replacement Prosthesis

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	Uncemented Hip Prosthesis
	Femoral Prosthesis
	Porous Coated Hip Prosthesis
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
	21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
	21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3350
	Class II - 21 CFR 888.3353
	Class II - 21 CFR 888.3358
	Class II - 21 CFR 888.3360
	Class II - 21 CFR 888.3390
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous uncemented
	MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium Phosphate
	KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
	KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
	LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K982918/K013350 - DePuy C-STEM™ System
	K042959/K082239/K220216 – DePuy C-STEM™ AMT Hip Prosthesis
	K093736 – DePuy CORAIL™ Revision Hip Prosthesis
	K851422 – DePuy S-ROM™ Femoral Total Hip System
	K910664 - DePuy S-ROM™ Total Hip System
	K934412 - DePuy S-ROM™ Coated ZT Proximal Hip System
	K961939 - DePuy S-ROM™ Femoral Hip Stem (Sizes 12x06x115 & 12x07x115)
	K073570 - DePuy Tri-Lock Bone Preservation Stem
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy willconsistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
	Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
	with corresponding material descriptions.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	C-STEMTM Product Family
	The DePuy C-STEMTM System includes stainless steel femoral stems, a gelatin end cap and PMMA
centralizers. The C-STEMTM is a collarless, slim profiled, triple tapered and overall polished stem
that is available in four stem designs. The four stem designs are: a CDH stem available in one size;
a primary stem available in eight sizes (1,2,3,4,5,6,7,8); a high offset stem available in three sizes
(3,4 and 5); and a revision stem available in three sizes (4,6 and 8) each of which is available in two
lengths (200mm and 240mm).
	The DePuy C-STEMTM AMT hip is a collarless, tapered, press-fit femoral stem. It is manufactured
from wrought stainless steel (Ortron 90® conforming to ISO 5832-9) and is polished overall. The
stem is offered in 7 sizes, with each body size having either a standard or high offset. It may be
used with commercially available modular femoral heads, either metal or ceramic, to form the
femoral component of a total hip prosthesis. Accessory items include previously cleared cement
restrictors and centralizers.
	CORAIL Product Family
	The DePuy CORAILTM Revision hip stems are manufactured from forged titanium alloy (Ti6Al4V) and
plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stems consists of a wide
range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail
stems are available with or without a collar, with various neck angles, and with various neck offsets.
	S-ROM Product Family

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The DePuy S-ROM™ Total Hip System is a modular system for use in total hip replacement. The system includes several types of femoral stems, various types of proximal sleeves, cobalt-chromium and ceramic femoral heads, various types of acetabular shells, acetabular liners, trochanter screws, trochanter washers, peripheral screws, locking pins, and apical hole plugs, all distributed by representatives of DePuy. The femoral stem uses a nominal 11-13 Morse-type taper and is composed of titanium alloy (Ti-AL6-V4). It is supplied in a variety of lengths and diameters. It is also available with a variety of neck lengths and in several different neck designs, as follows: a standard neck design, a standard neck design with increased offsets, a calcar replacement design and a calcar replacement design with increased offsets. The stem is compatible with S-ROM Total Hip System femoral heads, both cobalt chromium alloy (Co-Cr-Mo) and ceramic.

The DePuy S-ROM™ Coated ZT Proximal Hip Stem is a modular hip prosthesis system which achieves proper fit and fill through its modularity. The femoral side achieves this through the use of a stem/sleeve (collar) combination which is available in a variety of stem/sleeve/cone sizes as currently marketed for the ZT sleeve. The basic ZT sleeve is an elliptical TicAl4V non-cemented proximal femoral sleeve the shape of which matches the anatomy (contour of the bone). There is a 3 per side taper conical fit of the sleeve on the stem. It's exterior is stepped to maximise compressive stresses and minimize hoop and shear stress.

The DePuy S-ROM™ Femoral Hip Stems (Sizes 12x06x115 and 12x07x115) are manufactured from TigAl4V, the same material used to manufacture the S-RO femoral hip stems in the larger sizes and that has been used in orthopaedic implants for many years with established clinical success. The S-ROM Femoral Hip Stems are anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The size 12x06x115 and 12x07x115 stems, as well as the larger size S-ROM femoral hip stems, can be used in either the right or left hip.

Tri-Lock BPS

The Tri-Lock Bone Preservation Stem (BPS) is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral heads and articulates with DePuy acetabular cups.

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| | The Tri-Lock BPS has a flat, tapered stem design, with a modular head, 12/14 taper, proximal ML
geometry. It is proximally coated with porous coating, manufactured of titanium alloy conforming
to ASTM F-620. The Tri-Lock BPS utilizes the neck geometry (130° neck angle) of the Summit stem
cleared in K001991. The stem comes in thirteen sizes, with each size available in both high and
standard offsets via direct lateralization. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Intended use of the device | Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing
the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to
seat and support the components. |
| Indications for use | Total hip replacement is indicated in the following conditions: |
| | 1.
A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
2.
Avascular necrosis of the femoral head.
3.
Acute traumatic fracture of the femoral head or neck.
4.
Failed previous hip surgery including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip
replacement.
5.
Certain cases of ankylosis.
The DePuy C-STEM™ Hip Stems are indicated for cemented use only.
HA-coated stems of the CORAIL™ Hip System are indicated for cementless use only. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling |
| | for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners, |
| | Femoral Heads, and Hip Components, to provide updated information regarding the MRI |
| | compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels |
| and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients. At the same time as making these labeling updates in relation to MRI compatibility, DePuy will take the opportunity to standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries. | |
| Additionally, in order to harmonize with International and EU labeling requirements, the labeling of subject devices which are sold Internationally will be further updated to also include a new Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and can be discarded by the end user. The labeling will also be updated to include a material code with corresponding material descriptions. | |
| There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the DePuy C-STEM™, CORAIL™ and S-ROM™ Hip Prosthesis in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. | |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	EMPHASYS™ Femoral Stem
Common or usual name	Total or Hemi-Hip Arthroplasty Prosthesis
Classification name	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3353
	Class II - 21 CFR 888.3360
	Class II - 21 CFR 888.3390
Product Code(s)	MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium
Phosphate.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
	KWL: Prosthesis, Hip, Hemi-, Femoral, Metal.
	KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented.
Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K211657 - DePuy EMPHASYST™ Femoral Stem
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The DePuy EMPHASYS™ Femoral Stem prosthesis includes HA-coated proximal trapezoidal and
distal quadrangular stems with tapered sides and proximal horizontal and distal vertical grooves in
four configurations (Collared Standard Offset, Collarless Standard Offset, Collared High Offset and
Collarless High Offset).
Intended use of the device	Total and hemi-hip arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound
bone to seat and support the components.
	Total or hemi-hip arthroplasty may be considered for younger patients if, in the opinion of the
surgeon, an unequivocal indication for total or hemi-hip replacement outweighs the risks associated
with the age of the patient and if limited demands regarding activity and hip joint loading can be
assured. This includes severely crippled patients with multiple joint involvement for whom a gain in
hip mobility may lead to an expectation of significant improvement in the quality of their lives.
Indications for use	Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Hemi-hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and |
| | 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with
internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcaptial and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not
require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be
adequately treated by hemi-hip arthroplasty. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
| | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Non-clinical testing is provided to support the conditional safety of the DePuy EMPHASYS™
Femoral Stem in the MR environment, including assessment of;
● Magnetically Induced Displacement Force (ASTM E2052-21) |
| | Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Endurance Cemented Hip Prosthesis
Endurance Calcar Hip Prosthesis
Common or usual name	Hip Prosthesis
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3350
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K942370 – DePuy Endurance Cemented Hip Prosthesis
	K961619 - DePuy Endurance Calcar Hip Prosthesis
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	DePuy Endurance
The DePuy Endurance Cemented Hip Prosthesis is manufactured from ASTM F-799 Forged Cobalt-
Chromium-Molybdenum alloy. The stem has a proximal anterior/posterior flange which is
intended to compress the bone cement during insertion, center the stem proximally, transfer
loads to the cement proximally, enhance torsional stability and resist subsidence. The DePuy
Cemented Hip Prosthesis has broadly raised edges and corners to prevent creating stress
concentrations in the cement mantle.
	DePuy Endurance Calcar
	The Endurance Calcar Hip Prosthesis is available in one size and two stem lengths. The Endurance
Calcar stems do not have a collar but do have a 2.25cm calcar platform which is used to seat the
implant. The Endurance Calcar is designed for use with cement and so has no sharp corners and
broadly radiused medial and lateral curves.
Intended use of the device	Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing
the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to
seat and support the components.
Indications for use	Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding |
| updated symbols glossaries. | |
| There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the DePuy Endurance and DePuy Endurance Calcar Cemented Hip Prosthesis in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. | |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Modular Cathcart Fracture System
Common or usual name	Hip Prosthesis
Classification name	21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3360
Product Code(s)	LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

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| Legally marketed device(s) to which

equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K903084 - Modular Cathcart Fracture System
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The Modular Cathcart System consists of two components which together allow the surgeon to
vary the neck length on existing hip implants.
The Modular Sleeve Spacer is a double tapered conical section which will be press fit onto the
neck of hip implants with neck taper outer diameters of 13.7mm or 16.0mm. For each sleeve size,
there are three outer taper dimensions referred to as 0mm, +5mm and +10mm. These numbers
indicate the extension added to the implant neck length by that corresponding taper. The
proximal outer diameter is the same for all three extensions and the different extension lengths
come from the different distances at which the taper angle originates on the sleeve.
The Cathcart balls, produced from cast Orthochrome, are designed to mate with the sleeves in
press-fit applications. All balls have the same inner taper dimensions to fit all sleeve tapers. Neck
length adjustment is achieved by variations in the external and internal taper dimensions of the
	sleeve taper. The Cathcart (out-of-round) shaped ball will be available in outer diameter sizes
ranging from 41-60mm. These sizes allow for optimal sizing and revision fit.
Intended use of the device	The Modular Cathcart Fracture System is intended for use with existing hip stems as the femoral
neck and head prosthesis in total hip arthroplasty or as an endoprosthesis.
Indications for use	Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
2.
Avascular necrosis of the femoral head.
3.
Acute traumatic fracture of the femoral head or neck.
4.
Failed previous hip surgery including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip
replacement.
5.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
| There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the Modular Cathcart Fracture System in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. | |

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51

52

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	RECLAIMTM Revision Hip System
RECLAIMTM Monobloc Revision Femoral Stem
Common or usual name	Hip Stem Prosthesis
Classification name	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3353
Product Code(s)	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
K221462 - DePuy RECLAIM™ Monobloc Revision Femoral Stem
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The RECLAIM™ Modular Revision Hip System is a modular, three-component system consisting of
a proximal body, a distal stem and a locking bolt assembly. The proximal bodies and distal stems
are fitted with mating tapers that permit numerous proximal body/distal stem combinations and
	unlimited rotational positioning of the stem and version of the proximal body. The locking bolt assembly includes a bolt, locking washer and a polymeric retaining clip used to secure the washer to the bolt shank. Proximal bodies and distal stems are offered in a variety of lengths and diameters to accommodate a wide breadth of anatomy. Locking bolt assemblies are supplied in the length corresponding to the proximal body.
	The DePuy RECLAIM™ Monobloc Revision Femoral Stems are revision femoral implants made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity, and in contact with the cortical bone in the canal in an uncemented use. The extramedullary region has standard and high offset options on a polished neck, with a 12/14 AMT trunnion. The devices are intended to be inserted into the femoral canal using the Reclaim Monobloc inserter instruments.
Intended use of the device	Total Hip Arthroplasty Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Indications for use	The DePuy RECLAIM™ Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components, to provide updated information regarding the MRI compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and is reported within the 510(k), and appropriate amends have been made to the product labels and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.

At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.

There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.

Non-clinical testing is provided to support the conditional safety of the DePuy RECLAIM™
Revision Stems in the MR environment, including assessment of;
Magnetically Induced Displacement Force (ASTM F2052-21)

Magnetically Induced Displacement Torque (ASTM F2213-17)
●
Radio Frequency (RF) Heating (ASTM F2182-19)
●
Image Artifacts (ASTM F2119-07)
●
The non-clinical performance data demonstrate that the Subject Devices, when exposed to the

MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy.

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55

56

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Vision Solution Hip Prosthesis
Solution System Hip Prosthesis
Common or usual name	Cemented or Cementless Porous Coated Hip Prosthesis
Classification name	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3358
Product Code(s)	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
K953703 - DePuy Vision Solution Hip Prosthesis
K030979/K060581 - DePuy Solution System Hip Prosthesis
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.

There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| Device description | The DePuy Vision Solution Hip Prosthesis are made from ASTM F-75 Cobalt-Chrome-Molybdenum
alloy and have a sintered cobalt-chrome molybdenum alloy bead porous coating (Porocoat)
applied to the stem. The stems are indicated for cemented or cementless use.

The DePuy Solution System Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-
Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum
alloy bead porous coating (Porocoat) applied to the stem. The porous coating is applied to the |
| | entire stem with the exception of the tapered stem tip region. The stems are available in 10.5,
12.0 and 13.5mm sizes. |
| Intended use of the device | The DePuy Solution Hip Prosthesis are indicated for uncemented or cemented use as the femoral
components in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has
been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the
failure of a previous arthroplasty. |
| Indications for use | Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.

Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
The Solution Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth
into the porous coating as well as cemented use and fixation in which the porous coating serves
as a means to augment the fixation of the prosthesis to the bone cement. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will |
| | take the opportunity to standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries. |
| | There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. |
| | Non-clinical testing is provided to support the conditional safety of the DePuy Solution Hip Prosthesis in the MR environment, including assessment of; |
| • | Magnetically Induced Displacement Force (ASTM F2052-21) |
| • | Magnetically Induced Displacement Torque (ASTM F2213-17) |
| • | Radio Frequency (RF) Heating (ASTM F2182-19) |
| • | Image Artifacts (ASTM F2119-07) |
| | The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. |

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60

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	SUMMITTM Porocoat Hip Prosthesis
	SUMMITTM DuoFix Hip Prosthesis
	SUMMITTM Cemented Hip Prosthesis
	SUMMITTM FX Cemented Hip Prosthesis
	SUMMITTM Basic Press-Fit Hip Prosthesis
	ACTISTM Duofix Hip Prosthesis
	ACTISTM Duofix Hip Prosthesis Collarless
	CORAILTM AMT Hip Prosthesis
Common or usual name	Hip Joint Replacement Prosthesis with porous coating
	Hip Joint Replacement Prosthesis
	Uncemented Hip Prosthesis
Classification name	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
	21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
	21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3353
	Class II - 21 CFR 888.3358
	Class II - 21 CFR 888.3350
	Class II - 21 CFR 888.3360
	Class II - 21 CFR 888.3390
Product Code(s)	MEH: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented
	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
	LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
	KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
	KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
	Uncemented
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K001991 – DePuy SUMMIT™ Porocoat Hip Prosthesis
	K011489 – DePuy SUMMIT™ DuoFix Hip Prosthesis
	K013352 - DePuy SUMMIT™ Cemented Hip Prosthesis
	K023453 – DePuy SUMMIT™ FX Cemented Hip Prosthesis
	K030122 – DePuy SUMMIT™ Basic Press-Fit Hip Prosthesis
	K202472 - DePuy ACTIS™ Duofix Hip Prosthesis
	K210581 – DePuy ACTIS™ Duofix Collarless Hip Prosthesis
	K192946 – DePuy CORAIL™ AMT Hip Prosthesis
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to standardize language and symbols used across its legacy
devices for consistency, including the use of new internationally recognized symbols with
corresponding updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
	of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
	with corresponding material descriptions.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	SUMMIT Product Family
The DePuy SUMMIT™ Porous Hip is a collarless, titanium, tapered, press-fit femoral stem. The hip
stem is manufactured from Titanium (Ti6Al4V) and has a sintered commercially pure titanium
bead porous coating (Porocoat) applied to the stem. The hip stem consists of 11 body sizes
ranging in diameter from 6mm to 18mm with each body size having two offset options.
	The DePuy SUMMIT™ DuoFix Hip is a non-modular, collarless, Titanium, tapered, press-fit
femoral stem. The hip stem is manufactured from ASTM F-620-87 forged Titanium (Ti6Al4V) and
has a sintered commercially pure Titanium bead porous coating (Porocoat) applied to the stem.
The porous coating is applied over the circumferential ridges on the proximal region of the stem.
The ridges effectively act as small internal collars and turn shear loading of the bone into
compressive loading.
	The SUMMIT™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral
stem with a smooth surface finish. There are 7 proportional body sizes with two offset options.
Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.
	The SUMMIT™ FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral
stem with a smooth surface finish. The SUMMIT™ FX Cemented Hip Stem is offered in 7 sizes
with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the
femoral canal. The stem is designed specifically to treat femoral head and neck fractures but can
be used for any of the indications listed below.

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The SUMMIT™ Basic Press-Fit Hip Stem is a collared, tapered Titanium femoral stem with a grit blasted finish. The Summit Basic Press-Fit Hip Stem is offered in 7 sizes with a constant neck offset. The stem is intended for cementless, press-fit fixation and is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.

ACTIS Product Family

The DePuy ACTIS™ DuoFix prostheses are manufactured from forged titanium alloy (TiçAl♪) and have a sintered commercially pure titanium bead porous coating (Porocoat) and a thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

The ACTIS™ DuoFix Hip Prosthesis – Collarless is manufactured from the exact same materials to that of the collared prosthesis to meet the need of surgeons whose preference is to use a femoral stem without a collar for hip arthroplasty.

CORAIL Product Family

The DePuy CORAIL™ AMT hip stems are manufactured from forged titanium alloy (TiçAlൂV) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stems consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail stems are available with or without a collar, with various neck angles, and with various neck offsets.

65

Intended use of the device	Total and hemi-hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of satisfactory acetabulum and sufficient sound bone to seat and support the components.
Indications for use	Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Hemi hip replacement is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. |

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Substantial Equivalence
DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components, to provide updated information regarding the MRI compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and is reported within the 510(k), and appropriate amends have been made to the product labels and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients. At the same time as making these labeling updates in relation to MRI compatibility, DePuy will take the opportunity to standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries. Additionally, in order to harmonize with International and EU labeling requirements, the labeling of subject devices which are sold Internationally will be further updated to also include a new Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and can be discarded by the end user. The labeling will also be updated to include a material code with corresponding material descriptions. There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. Non-clinical testing is provided to support the conditional safety of the DePuy SUMMIT™, DePuy ACTIS™ Duofix, and DePuy CORAIL™ Hip Prosthesis in the MR environment, including assessment of; Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19)
• Image Artifacts (ASTM F2119-07)
The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy.

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68

ACETABULAR PRODUCTS 510k Summaries

69

Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Trade or proprietary name	PINNACLE™ Dual Mobility Liner
Common or usual name	Acetabular Cup Prosthesis
Classification name	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3358
Class II – 21 CFR 888.3353
Product Code(s)	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium
Phosphate.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
K200854 – DePuy PINNACLE™ Dual Mobility Liner
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The DePuy PINNACLE™ Dual Mobility Liner is manufactured from cobalt-chromium-molybdenum
alloy. The Liner is assembled with a taper locking mechanism to PINNACLE™ Acetabular Shells.
The inner surface of the Dual Mobility Metal Liner articulates with a BI-MENTUM™ polyethylene
	mobile 54 bearing head. The Dual Mobility construct is compatible with DePuy metal or ceramic
modular femoral heads, for use in total hip arthroplasty.
The PINNACLETM Dual Mobility Metal Liner is intended to be used in total hip arthroplasty with a
PINNACLETM Acetabular Cup, a BI-MENTUMTM Dual Mobility Polyethylene Liner, a DePuy femoral
stem and a DePuy modular, femoral head.
Intended use of the device	The PINNACLETM Dual Mobility Metal Liners are designed to provide additional stability where
there is an unstable joint and are for use in total hip arthroplasty which is intended to provide
increased patient mobility and reduce pain by replacing the damaged hip joint articulation in
patients where there is evidence of sufficient sound bone to seat and support the components.
The PINNACLETM Dual Mobility Metal Liners are intended for single use only.
Indications for use	Total hip replacement or hip arthroplasty is indicated in the following conditions:

A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint
disease).
Failed previous hip surgery.
Dislocation risks.
PINNACLETM Dual Mobility Metal Liners and Porous-coated PINNACLETM Acetabular Cups are
intended for cementless applications. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels |
| and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries. | |
| There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the DePuy PINNACLE™ Dual
Mobility Liner in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. | |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
	Ringaskiddy
	Co. Cork
	Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	BI-MENTUM™ ALTRX® Dual Mobility Liners
Common or usual name	Acetabular Component
Classification name	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3353

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| Product Code(s) | LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented
MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium
Phosphate |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Legally marketed device(s) to which | Primary Predicate – K102080 – RECLAIM™ Revision Hip System |
| equivalence is claimed | K203532 - BI-MENTUM™ ALTRX® Dual Mobility Liners |
| Reason for 510(k) submission | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| Device description | The BI-MENTUM™ ALTRX® Dual Mobility Liner is highly cross-linked ultrahigh molecular weight
polyethylene (UHMWPE). The liner is mobile (free) in the metallic shell and retained on the
prosthetic femoral head. |
| Intended use of the device | BI-MENTUM™ ALTRX® Dual Mobility Liners are designed to provide additional stability where
there is an unstable joint and are for use in total hip arthroplasty that is intended to provide |
| | increased patient mobility and reduce pain by replacing the damaged hip joint articulation or a
previously implanted prosthetic hip joint in patients where there is evidence of sufficient sound
bone to seat and support the components. The Bi-Mentum Altrx Dual Mobility Liners are
intended for single use only. |
| Indications for use | BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement in the following
conditions:

Osteoarthritis
Femoral neck fracture
Dislocation risk
Osteonecrosis of the femoral head
Revision procedures where other treatments or devices have failed are if bone
reconstruction so permits |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| | Non-clinical testing is provided to support the conditional safety of the BI-MENTUM™ ALTRX®
Dual Mobility Liners in the MR environment, including assessment of; |
| • | Magnetically Induced Displacement Force (ASTM F2052-21) |
| • | Magnetically Induced Displacement Torque (ASTM F2213-17) |
| • | Radio Frequency (RF) Heating (ASTM F2182-19) |
| • | Image Artifacts (ASTM F2119-07) |
| | The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	PINNACLETM AltrX Acetabular Liners
PINNACLETM 100 with GRIPTIONTM Acetabular Cups
PINNACLETM with GRIPTIONTM Acetabular Cups
PINNACLETM Acetabular Enhanced Stability Liners
Common or usual name	Polyethylene Acetabular Cup Liner
Acetabular Cup with Porous Coating
Acetabular Cup Prosthesis
Classification name	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
	21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3358
	Class II - 21 CFR 888.3353
	Class II - 21 CFR 888.3350
Product Code(s)	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
	Uncemented.
	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K072963 - DePuy PINNACLE™ AltrX Acetabular Liners
	K102423 - DePuy PINNACLE™ AltrX Acetabular Liners
	K132959 - DePuy PINNACLE™ AltrX Acetabular Liners
	K090998 - DePuy PINNACLE™ 100 with GRIPTION™ Acetabular Cups
	K093646 - DePuy PINNACLE™ with GRIPTION™ Acetabular Cups
	K033273 - DePuy PINNACLE™ Acetabular Enhanced Stability Liners
	K001534 - DePuy PINNACLE™ Acetabular System
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
	is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
	Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	PINNACLE™ AltrX
The DePuy PINNACLE™ AltrX Acetabular Liner is part of a modular system designed to replace the
natural articular surface of the hip joint in total hip replacement. The liner is manufactured from
ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated,
hemispherical outer shell component manufactured from titanium alloy (Ti6Al4V). The liner
component articulates with a metal or ceramic femoral head of an appropriate diameter.
The PINNACLE™ AltrX Liners are cross-linked UHMWPE acetabular cup liners that are available in
a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The subject liners
are intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral
heads within the 28mm-48mm size range.

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PINNACLE™ with GRIPTION™

The PINNACLE™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (TigAlൂV) and a liner manufactured from ultra high molecular weight polyethylene (UHMWPE) or high-carbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. The subject acetabular cup is coated with a proprietary titanium porous coating, GRIPTION™.

PINNACLE™ Enhanced Stability Liner

The PINNACLE™ Enhanced Stability (ESL) Marathon™ liners are cross-linked UHMWPE acetabular cup liners that are available in a lateralized neutral, or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with modular, unipolar, or self-centering (bipolar) femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering. There is an addition of a Charnley-style bore on sizes 36mm-48mm ID to increase stability.

PINNACLE™ Acetabular System

The DePuy PINNACLE™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (TigAl4V) and a liner manufactured from ultra-high molecular weight polyethylene (UHMWPE), which looks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

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| Intended use of the device | Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing
the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to
seat and support the components.

PINNACLETM AltrX
The DePuy PINNACLETM AltrX Acetabular Liner is intended to be used with DePuy PINNACLETM
metal acetabular shells, and DePuy metal or ceramic femoral heads to resurface the acetabular
socket in cementless total hip arthroplasty.

PINNACLETM with GRIPTIONTM
The DePuy PINNACLETM GRIPTIONTM porous-coated Acetabular Cup total hip components are
indicated for cementless use with fixation provided by biological tissue ingrowth into the porous
coating.

PINNACLETM Enhanced Stability Liner
The ESL MarathonTM Polyethylene Liners are intended to be used with the DePuy PINNACLETM
metal acetabular shells, modular femoral heads, unipolar femoral heads, and self-centering heads
to resurface the acetabular socket in cementless total hip arthroplasty.

PINNACLETM Acetabular System
All Pinnacle porous-coated acetabular shells are indicated for cementless application. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck. |
| | 4.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
| | Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions. |
| | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| | Non-clinical testing is provided to support the conditional safety of the DePuy PINNACLETM
Acetabular System, DePuy PINNACLETM Altrx, PINNACLETM with GRIPTIONTM and PINNACLETM
Enhanced Stability Acetabular Cups and Liners in the MR environment, including assessment of; |
| | Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	PINNACLE™ Revision System
PINNACLE™ Duofix HA Acetabular Cup Prosthesis
DURALOC™ Option Acetabular Cup System
DURALOC™ 100C Acetabular Cup
DURALOC™ Cementless Acetabular Cup System
MARATHON™ Cross-linked Polyethylene Acetabular Cup Liners
36mm MARATHON™ Polyethylene Liners
Profile Hip Acetabulum Prosthesis
EMPHASYS™ Acetabular System
Common or usual name	Acetabular Cup Prosthesis
Cementless Acetabular Cup Prosthesis
Classification name	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
	21 CFR 888.3353: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-
Porous, Uncemented.
	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3358
	Class II – 21 CFR 888.3353
	Class II – 21 CFR 888.3350
Product Code(s)	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K033338 – DePuy PINNACLE™ Revision System
	K192919 – DePuy PINNACLE™ Duofix HA Acetabular Cup Prosthesis
	K040544 – DePuy DURALOC™ Option Acetabular Cup System
	K951674 - DePuy DURALOC™ 100C Acetabular Cup
	K961186 - DePuy DURALOC™ Cementless Acetabular Cup System
	K994415 – DePuy MARATHON™ Cross-linked Polyethylene Acetabular Cup Liners
	K010171 - DePuy 36mm MARATHON™ Polyethylene Liners
	K863184 - DePuy Profile Hip Acetabulum Prosthesis
	K221636 – DePuy EMPHASYS™ Acetabular System
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	PINNACLE™ Revision System
The PINNACLE™ Revision System is a modular system for resurfacing the acetabulum in total hip
arthroplasty. The system consists of two separate units, a shell and a liner. The shell substrate is
manufactured from forged or wrought titanium alloy (Ti6Al4V). The outer porous coating
(Porocoat) consists of commercially pure titanium beads metallurgically bonded to the shell
substrate. The interior of the shell is designed to mate with a variety of styles of liners that lock
into the shell. The liner is manufactured from Ultra-high molecular weight polyethylene
(UHMWPE). The liners contain multiple ARDs (anti-rotation devices) that engage mating shell
features to prevent rotation within the shell. The ARDs enable variable rotational alignment of
Face Changing (+4/10) and lipped liners for patient appropriate positioning. The acetabular liner
articulates with a compatible femoral head of appropriate diameter.
PINNACLE™ Duofix HA
The PINNACLE™ Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®)
hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin
layer of hydroxyapatite (HA) coating applied.
The interior of the acetabular cup is designed with a groove and a taper for use with either an
ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock
into the shell. Articulation occurs between the liner, and a femoral head with the appropriately
sized diameter.
The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion
instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical
hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to
occlude the apical hole in order to prevent particulate migration and provide polyethylene
support.
The PINNACLE™ Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm
through 66mm in both the "No Hole” (100 series) and the "Cluster Hole" (Sector series)
configurations.
DURALOC™ Option
The DURALOC™ Option Acetabular Cup System consists of a UHMWPE acetabular cup liner
secured to a porous-coated Ti-6Al-4V acetabular shell. The acetabular system articulates with
previously cleared 22.225mm or 28mm femoral heads.
The acetabular cups are sized from 44mm to 66mm, in 2 mm increments. The liners are available
in two styles: neutral and lipped. Liners with a 22.225mm inner diameter are offered in outer
diameters of 44mm and 46mm. Liners with a 28mm inner diameter are offered in outer
diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.
The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring,
manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.
DURALOCTM 100C Cup
The DePuy DURALOCTM 100C is a porous coated Co-Cr-Mo alloy acetabular cup which is available
in 10 sizes, ranging from 48mm to 66mm in outer diameter. The porous coated outer surface is
intended to achieve biological fixation through tissue ingrowth, or to enhance the strength of the
bone cement/prosthesis interface if the cup is used with bone cement. The DePuy DURALOCTM
100C also features a polished inner surface. This surface is in full congruent contact with the
polyethylene liner, assuring full dome loading of the polyethylene.
DURALOCTM Cementless Acetabular Cup
The DePuy DURALOCTM Cementless Acetabular Cups are all porous coated Ti6Al4V alloy acetabular
cup metal shells and will be available in various sizes with outer diameters ranging from 38mm to
80mm. All of the cups have screw holes, either dome or peripheral, for adjunctive fixation. All of
the DePuy DURALOCTM Acetabular Cups are intended to be used with DePuy DURALOCTM
polyethylene liners and locking rings to resurface the acetabular socket in cemented or
cementless total hip replacement.
DePuy MARATHONTMCross-linked Polyethylene Acetabular Cup Liners
The DePuy MARATHONTMCross-linked Polyethylene Acetabular Cup Liners are UHMWPE acetabular
cup liners that are available with 28mm or 32mm inner diameters and with a neutral or 10° lip. The
28mm liners are available in sizes to fit DURALOCTM metal acetabular shells with outer diameters
of 48-74mm. The 32mm liners are available in sizes to fit DURALOCTM metal acetabular shells with

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outer diameters of 52-80mm. The polyethylene liners are locked into the DURALOC™ metal shells with a metal wire locking ring which is supplied with the metal shells.

The DePuy MARATHON™Cross-linked Polyethylene Acetabular Cup Liners are manufactured from UHMWPE that has been cross-linked by exposure to radiation in a very low oxygen environment and then heat treated prior to machining of the liners. The cross-linked polyethylene has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation and wear. Marathon cross-linked UHMWPE meets all of the specifications of ASTM F648.

The DePuy MARATHON™36mm liners are UHMWPe acetabular cup liners that are available with a 36mm inner diameter and are lateralized 4mm. They are available in a neutral orientation and with a 10degree lip. They are geometrically identical to other DURALOC™ Acetabular Cup Liners with the exception of having a larger (36mm) inner diameter intended for use with 36mm femoral heads.

DePuy Profile Hip Acetabulum Prosthesis

The DePuy Profile Hip Acetabulum Prosthesis manufactured from ASTM-F-136 Titanium-Aluminium-Vanadium alloy (TigAl4V). The porous coating is manufactured from ASTM-F-67 Commercially Pure (CP) Titanium. The prosthesis articulates with the Profile Hip Femoral Prosthesis. The Profile Hip Acetabulum prosthesis can also be utilized with other femoral prostheses having a head size that matches the inner diameter of the Profile Hip Acetabular prosthesis.

EMPHASYS™ Acetabular System

The EMPHASYS™ Acetabular System includes porous-coated acetabular shells in three configurations (No-Hole, 3-Hole and Multi-Hole) and AOX polyethylene liners in three configurations (Neutral, +4 Neutral and ELV).

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| Intended use of the device | Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | PINNACLETM Revision Acetabular System |
| | The PINNACLETM Revision Acetabular System is intended to be used to resurface the acetabular
socket in cemented or cementless total hip arthroplasty. |
| | PINNACLETM Duofix HA |
| | The PINNACLETM Duofix HA Acetabular Cup Prosthesis is indicated for cementless application. |
| | DURALOCTM Option |
| | The DURALOCTM Option Acetabular Cup System is indicated for cementless application. |
| | DURALOCTM 100C Cup |
| | The DePuy DURALOCTM 100C Cup is intended to be used with the DURALOCTM polyethylene liners
to resurface the acetabular socket in cemented or cementless total hip replacement. |
| | DURALOCTM Cementless Acetabular Cup |
| | The DePuy DURALOCTM Cementless Acetabular Cups are intended to be used with DURALOCTM
polyethylene liners to resurface the acetabular socket in cemented or cementless total hip
replacement. |
| | DePuy MARATHONTMCross-linked Polyethylene Acetabular Cup Liners |
| | The DePuy MARATHONTMCross-linked Polyethylene Acetabular Cup Liners are intended to be used
with the DePuy DURALOCTM metal acetabular shells to resurface the acetabular socket in cemented
or cementless total hip replacement. |
| | DePuy Profile Hip Acetabulum Prosthesis
The DePuy Profile Hip Acetabulum Prosthesis is designed to be implanted with bone cement. |

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	EMPHASYS™ Acetabular Cups
	The system is intended for use with a compatible DePuy femoral stem and modular head as a
total hip prosthesis. EMPHASYS™ Acetabular Cups are indicated for cementless use only.
Indications for use	Total hip arthroplasty is indicated for total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| | |
| Non-clinical testing is provided to support the conditional safety of the PINNACLE™ Revision | |
| System, PINNACLE™ Duofix HA, DURALOC™ Option Acetabular Cup System, DURALOC™ 100C | |
| Cup, DURALOC™ Cementless Acetabular Cup, MARATHON™Cross-linked Polyethylene Acetabular | |
| Cup Liners, Profile Hip Acetabulum Prosthesis and EMPHASYS™ Acetabular System in the MR | |
| environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) | |
| Magnetically Induced Displacement Torque (ASTM F2213-17) | |
| Radio Frequency (RF) Heating (ASTM F2182-19) | |
| Image Artifacts (ASTM F2119-07) | |
| | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the | |
| MR environment under specific MR conditions of use, raise no new questions of safety or | |
| efficacy. | |
| | |

92

93

FEMORAL HEADS 510k Summaries

94

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Delta Ceramic Femoral Heads
Delta TS Ceramic Femoral Heads
Elite Femoral Head
Common or usual name	Ceramic Femoral Ball Prosthesis
Temporary Hip Joint Replacement Prosthesis
Classification name	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3353
	Class II - 21 CFR 888.3350
Product Code(s)	LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
K011533, K031803, K062748 - DePuy Delta Ceramic Femoral Heads
K071830 - DePuy Delta TS Ceramic Femoral Heads
K871867 - DePuy Elite Femoral Heads
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	Delta Femoral Heads
The DePuy Delta Ceramic Femoral Heads are ceramic femoral ball prostheses, comprised of an
alumina composite material, intended for use with DePuy femoral hip stems with a
corresponding taper design. The ceramic femoral heads mechanically lock with a femoral hip
stem via a taper junction and articulate with a polyethylene acetabular component.
	The DePuy Delta TS (Taper Sleeve) Ceramic Femoral Heads are designed for use as the femoral
head component in total hip arthroplasty procedures. The femoral head is manufactured from an
alumina composite ceramic material and includes an internal titanium alloy sleeve to mate with
DePuy femoral hip stems with a corresponding taper. The ceramic femoral head mechanically
locks with the femoral hip stem via a taper junction and articulates with a polyethylene
acetabular component.
The DePuy Delta TS Ceramic Femoral Heads are available in femoral head outer diameters of
28mm, 32mm, 36mm, 40mm and 44mm. The internal bore of the titanium sleeve is available in a
12/14 option.
	Elite Femoral Heads
The DePuy Elite Femoral Heads are sterile, single use, high nitrogen stainless steel implants
intended for use with modular femoral stems in Hemi-Hip Arthroplasty (HHA) or Total Hip
Arthroplasty (THA).
Intended use of the device	Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components.
Indications for use	DePuy Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty
procedures. Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid
arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new |
| | |
| | Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and can be discarded by the end user. The labeling will also be updated to include a material code with corresponding material descriptions. |
| | There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. |
| | Non-clinical testing is provided to support the conditional safety of the DePuy Delta and Elite Femoral Heads in the MR environment, including assessment of; |
| • | Magnetically Induced Displacement Force (ASTM F2052-21) |
| • | Magnetically Induced Displacement Torque (ASTM F2213-17) |
| • | Radio Frequency (RF) Heating (ASTM F2182-19) |
| • | Image Artifacts (ASTM F2119-07) |
| | The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. |

95

96

97

98

99

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg, Ringaskiddy
Co. Cork Munster, P43 ED82,
IRELAND
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Self-Centering Hip
Common or usual name	Total or Hemi-Hip Arthroplasty Prosthesis
Classification name	21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3390
Product Code(s)	KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented.

100

Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K812672 - DePuy Self-Centering Hip
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The DePuy Self-Centering Hip device is a femoral, hemi-hip (metal/polymer) prosthesis designed to
replace the femoral head and consists of 2 major parts: a metallic alloy outer shell, and a 2 piece
Ultra High Molecular Weight Polyethylene (UHMWP) bearing insert and metal retaining ring,
assembled for use in conjunction with any metallic alloy total hip femoral component with a 22mm
or 32mm diameter head.
Intended use of the device	SELF-CENTERING Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is
evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the
femoral stem.
Indications for use	Self-Centering hip arthroplasty is indicated in the following conditions: Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. Avascular necrosis of the femoral head. Non-union of femoral neck fractures. Certain high subcapital and femoral neck fractures in the elderly. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners, Femoral Heads, and Hip Components, to provide updated information regarding the MRI compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and is reported within the 510(k), and appropriate amends have been made to the product labels and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients. At the same time as making these labeling updates in relation to MRI compatibility, DePuy will take the opportunity to convert to a paperless, electronic IFU format, standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices.

101

102

103

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	HPS Femoral Ball Head
Total Hip Ball Femoral Head
Articul/eze Femoral Heads
Modular M Head
36mm Femoral Heads
Articul/eze Ceramic Heads
Common or usual name	Femoral Prosthesis
Temporary Hip Joint Replacement Prosthesis
Femoral Heads

104

	Ceramic femoral ball prosthesis
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
	21 CFR 888.3358: Hip joint metal/polymer/metal, semi-constrained, porous-coated, uncemented
prosthesis.
	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3350
	Class II – 21 CFR 888.3358
	Class II – 21 CFR 888.3353
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K860701 - DePuy HPS Femoral Ball Heads
	K880269 - DePuy Total Hip Ball Femoral Heads
	K883460 - DePuy Articul/eze Femoral Heads
	K060031 - DePuy Modular M Heads
	K980513/K120599 - DePuy 36mm Femoral Heads
	K222296 - Articul/eze Ceramic Heads
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,

105

| | Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| Device description | HSP and Total Hip Femoral Heads
The DePuy HSP and Total Hip Femoral Ball Heads are made from ASTM F-75 Cobalt Chromium
Molybdenum. Femoral ball heads with corresponding internal tapers are available to allow for
interchangeability. The different femoral ball heads provide three different neck length and two
head sizes. |
| | Articul/eze Femoral Heads |
| | The DePuy Articul/eze Femoral Heads are sterile, single use, metal implants intended for use with
modular femoral stems in Hemi-Hip Arthroplasty (HHA) or Total Hip Arthroplasty (THA). The
products are intended for use in both Primary and Revision Hip Arthroplasty. |
| | The modular femoral heads are intended to replace the native femoral head and are
mechanically fixed to the modular femoral stems by means of a taper trunnion. The Modular
Femoral Head and Modular Femoral Stem components are assembled intraoperatively and
articulate against an appropriate acetabular component. |

106

Modular M Heads	The DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:
	40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -2, +1.5, +5, +8.5, +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems.
	40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 and +12 mm neck lengths. The 48 mm heads with the 11/13 taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems.
36mm Femoral Heads	The DePuy 36mm Femoral Heads are Co-Cr-Mo alloy femoral heads available in various taper sizes and offsets which are designed to mate with femoral hip stems which have matching neck taper sizes. The offset vary to allow the surgeon flexibility in lateralization of the hip joint.
ARTICUL/EZE Ceramic Heads	The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina composite ceramic femoral head designed to be used as one component of a system of prostheses in hip arthroplasty. The femoral heads are available in a wide range of outer diameter sizes and offsets.
Intended use of the device	Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Indications for use	Total hip replacement is indicated in the following conditions:

107

| | | 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia. |
|-------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 2. Avascular necrosis of the femoral head. |
| | | 3. Acute traumatic fracture of the femoral head or neck. |
| | | 4. Failed previous hip surgery including joint reconstruction, internal fixation,
arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip
replacement. |
| | | 5. Certain cases of ankylosis. |
| Substantial Equivalence | | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
| | | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Non-clinical testing is provided to support the conditional safety of the DePuy HPS, Total Hip
Femoral Ball Heads, DePuy Articul/eze, Modular M, 36mm Femoral Heads and ARTICUL/EZE
Ceramic Heads in the MR environment, including assessment of; |

108

| | • Magnetically Induced Displacement Force (ASTM F2052-21) • Magnetically Induced Displacement Torque (ASTM F2213-17) • Radio Frequency (RF) Heating (ASTM F2182-19) • Image Artifacts (ASTM F2119-07) The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. |

--

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

109

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	S-ROM Femoral Head
Common or usual name	Temporary Hip Joint Replacement Prosthesis
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3350
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.

110

Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K851422/K920317 – S-ROM Femoral Heads
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The S-ROM Femoral Heads, are a nitrogen ion implanted modular femoral head. They are
composed of wrought cobalt chrome alloy conforming to ASTM F799. The outer bearing surface is
spherical, finished to a high polish and implanted with Nitrogen lons. The bore of the S-ROM LF
Femoral Head is machined to a precise taper angle to mater with compatible S-ROM Femoral
Stems. The S-ROM Femoral Heads are offered in a variety of sizes.
Intended use of the device	INTENDED USE - TOTAL HIP PROSTHESIS
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components.

111

	INTENDED USE - HEMI-HIP PROSTHESIS
	Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence
of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral
stem.
Indications for use	INDICATIONS – TOTAL HIP PROSTHESIS
	Total hip replacement is indicated in the following conditions:
	1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid
arthritis, or congenital hip dysplasia.
	2. Avascular necrosis of the femoral head.
	3. Acute traumatic fracture of the femoral head or neck.
	4. Certain cases of ankylosis.
	INDICATIONS – HEMI-HIP PROSTHESIS
	Hemi-hip arthroplasty is indicated in the following conditions:
	1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated
with internal fixation.
	2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal
fixation.
	3. Avascular necrosis of the femoral head.
	4. Non-union of femoral neck fractures.
	5. Certain high subcapital and femoral neck fractures in the elderly.
	6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require
replacement.
	7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately
treated by hemi-hip arthroplasty.

112

| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| | Non-clinical testing is provided to support the conditional safety of the S-ROM Femoral Heads in
the MR environment, including assessment of; |
| | Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) |
| | The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. |

113

COMPONENTS 510k Summaries

114

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	5.0mm Tapered Head Peripheral Screw
Low Profile Bone Screw
Acetabular System Screws
Gription TF 5.5mm Locking Screws
Common or usual name	Acetabular Screw
Bone Screw
Acetabular Cup and Liner
Locking Screws
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener.
	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3050
	Class II – 21 CFR 888.3040
	Class II – 21 CFR 888.3358
	Class II – 21 CFR 888.3353
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
	HWC: Screw, Fixation, Bone.
	LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K861979 - 5.0mm Tapered Head Peripheral Screw
	K970929 - DePuy Low Profile Bone Screw
	K983014 - Acetabular System Screws
	K123924 - Gription TF 5.5mm Locking Screws
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
	is reported within the 510(k), and appropriate amends have been made to the product labels
	and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
	At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
	take the opportunity to standardize language and symbols used across its legacy devices for
	consistency, including the use of new internationally recognized symbols with corresponding
	updated symbols glossaries.

	Additionally, in order to harmonize with International and EU labeling requirements, the labeling
	of subject devices which are sold Internationally will be further updated to also include a new
	Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
	can be discarded by the end user. The labeling will also be updated to include a material code
	with corresponding material descriptions.

	There is no change to the indications, intended use, safety, fit, form or technological
	characteristics of the devices.

Device description	DePuy 5.0mm Tapered Head Peripheral Screw
	The DePuy 5.0mm Tapered Head Peripheral Screw provides a peripheral fixation in the DePuy
	Solution Cup System. It comes in 8 lengths in 5mm increments (25-60mm) with a 5.0mm
	diameter thread.
	The use of orthopedic screws provides the orthopedic surgeon a means of ancillary bone fixation
	in reconstructive surgeries. These implants are intended to provide additional stability to
	implanted orthopedic devices and are NOT intended to replace normal body structure or bear the
	weight of the body in the presence of incomplete bone healing.

	DePuy Low Profile Bone Screw
	The DePuy Low Profile Bone Screw, manufactured in both Ti6Al4V and Co-Cr-Mo alloys, are
	available in twelve lengths (15-10mm) with a 6.5mm major diameter. The head of the screw is
	designed with a "low profile" to allow the head to be placed below the surface of the component
	being fixed. An internal hex fitting in the head is used for instrument (a hex drive) insertion of the
	screw during surgery. The distal two-thirds of the screw is coarsely threaded while the proximal
	one-third is smooth with a polished stain finish. The screw has a distal flute to aid in insertion into
	cancellous bone.

	PINNACLE™ Cancellous Bone Screws and P.F.C Sigma Porocoat Tray Screws
	The DePuy PINNACLE™ Cancellous Bone Screws and P.F.C Sigma Porocoat Tray Screws are to be
	used with the Acetabular System. They are manufactured from titanium alloy (Ti-Al6-V4).

	DePuy Gription TF 5.5mm Locking Screws
	The DePuy Gription TF 5.5mm locking screws are used for mechanical fixation with the DePuy
	Gription TF Acetabular System, which consists of a variety of augments, buttresses and shims. The
	lengths include 14-24mm in increments of 2mm and lengths 25-70mm in increments of 5mm.

Intended use of the device	The DePuy Bone Screws are indicated for use in primary or revision hip surgery, namely for
peripheral screw fixation for acetabular cups.
Indications for use	The DePuy Bone Screws are indicated for use in primary or revision hip surgery, namely for
peripheral screw fixation for acetabular cups. DePuy Bone Screws are indicated for use as an
ancillary fixation device to be used with tibial and acetabular components in total knee and hip
arthroplasty.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will take the opportunity to standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling of subject devices which are sold Internationally will be further updated to also include a new Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and can be discarded by the end user. The labeling will also be updated to include a material code with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices.
Non-clinical testing is provided to support the conditional safety of the DePuy Bone Screws in the MR environment, including assessment of;
Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07)
The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.
Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
	Ringaskiddy
	Co. Cork
	Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Trade or proprietary name	GRIPTION™ TF Acetabular Augment System
Common or usual name	Acetabular Augments, Buttresses, Shims
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
	21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
	21 CFR 888.3353: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-
Porous, Uncemented
Class	III/II
Classification panel	87 Orthopedics
Regulation	Class II – 21 CFR 888.3350
	Class II – 21 CFR 888.3358
	Class II – 21 CFR 888.3353
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.
	LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous,
Uncemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
K100391 - DePuy GRIPTION™ TF Acetabular Augment System
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.

Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and |

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| | | | | can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions. |
|--------------------|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. |
| | | | | The scope of this submission incorporates the Hip Acetabular Augments, Buttresses and Shim
components solely, no Knee implant product codes are included. |
| Device description | | | | GRIPTION™ TF Acetabular Augments |
| | | | | The DePuy GRIPTION™ TF Acetabular Augment System provides an alternative to structural
allograft for augmenting moderate to large-sized segmental acetabular defects encountered in
acetabular reconstruction. The GRIPTION™ TF Acetabular Augment implants are manufactured
from Commercially Pure (CP) Titanium powder conforming to ASTM Specification F-1580. The
Acetabular Augment implants are used to fill an acetabular defect giving the acetabular shell
support where bone is missing or inadequate. The Augment has an inside diameter designed to
mate with the outside diameter of the Pinnacle Acetabular Shell system. The porous GRIPTION™
TF acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical
fixation. The Acetabular Augments incorporate screw holes that allow for the use of bone screws
for adjunct fixation of the acetabular component to the native bone. The Acetabular Augments
also incorporate a slot feature used to mechanically attach the augment to the acetabular shell
with or without the use of bone cement. The assembled porous titanium augment/acetabular
construct is intended for cemented or cementless use. |
| | | | | GRIPTION™ TF Acetabular Buttresses
The GRIPTION™ TF Acetabular Buttress implants are manufactured from Commercially Pure (CP) |
| | | | | Titanium powder conforming to ASTM Specification F-1580. The Acetabular Buttress implants are |

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| | used to span an acetabular defect, giving the acetabular shell support where bone is missing or
inadequate. The Buttress implants have a spherical diameter matching those of DePuy
Orthopaedics' current acetabular shell sizing. The porous GRIPTION™ TF Acetabular Buttress is
affixed to the mating acetabular cup using bone cement. The assembled porous titanium
buttress/acetabular construct is intended for cemented or cementless use. The Acetabular
Buttress implants also incorporate screw holes that allow for the use of bone screws for adjunct
fixation of the acetabular component to the native bone. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GRIPTION™ TF Shims
The GRIPTION™ TF Acetabular Shim implants are manufactured from Commercially Pure (CP)
Titanium powder conforming to ASTM Specification F-1580. The Acetabular Shim implants are
used to mate with the Buttress implants to raise or support the end of the Buttress when pelvic
geometries are not flat. The Shim implant has clearance holes for the Buttress screw adjunct
fixation. The porous GRIPTION™ TF Shim is affixed to the mating Buttress using bone cement. The
assembled porous titanium buttress/shim construct is intended for cemented or cementless use. |
| Intended use of the device | The DePuy GRIPTION™ TF Acetabular Augment System is intended to provide the orthopaedic
surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular
deficiencies. |
| Indications for use | The DePuy GRIPTION™ TF Acetabular Augments, Buttresses and Shims are indicated for use with
the Pinnacle Acetabular Cup System, the Pinnacle Bantam Acetabular Cup System and the
Pinnacle Revision Acetabular Cup System for total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck. |
| | 4.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.
The porous GRIPTIONTM TF titanium acetabular augment is affixed to the mating acetabular cup
using bone cement or mechanical screw fixation. The assembled porous titanium augment is
intended for cemented or cementless use.
The porous GRIPTIONTM TF titanium shim is affixed to the mating buttress using bone cement.
This porous GRIPTIONTM TF titanium buttress is affixed to the mating acetabular cup using bone
cement. The assembled buttress/acetabular cup construct is intended for cemented or
cementless use. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling |
| | of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code |
| with corresponding material descriptions. | |
| There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the DePuy GRIPTION™ TF Acetabular Augment System in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. | |

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December2023
Name of device
Trade or proprietary name	Cement Restrictor
Common or usual name	Cement Restrictor
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3050
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K800894 - DePuy Cement Restrictor
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to convert to a paperless, electronic IFU format, standardize language and
symbols used across its legacy devices for consistency, including the use of new internationally
recognized symbols with corresponding updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The DePuy Cement Restrictor is designed for placement in the prepared medullary canal to
restrict bone cement migration into the distal medullary canal on implantation of a femoral hip
prosthesis. This device is an ultra high molecular weight polyethylene cylinder with a threaded
	hole for attachment to the Insertion Instrument and having multiple rows of flexible segmented
fins to provide a mechanical fixation in the medullary canal.
Intended use of the device	The DePuy Cement Restrictor is indicated for use in cementing total hip or endoprosthetic
femoral components.
Indications for use	The UHMWPe cement restrictor is intended for use in cemented total and hemiarthroplasty
procedures to restrict distal flow of bone cement in the femoral medullary cavity.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
	Non-clinical testing is provided to support the conditional safety of the DePuy Cement Restrictors in the MR environment, including assessment of;
	Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.

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Name	DePuy Ireland UC
Address	Loughbeg
	Ringaskiddy
	Co. Cork
	Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Modified Profile Hip PMMA Cement Spacer
Common or usual name	Cement Spacer
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3050
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.

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| Legally marketed device(s) to which

equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K871510 - Modified Profile Hip PMMA Cement Spacer
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	Cementralizers® and cement spacers are polymethylmethacrylate (PMMA) spacers intended for
use in cemented total hip arthroplasty to provide a uniform thickness of bone cement between
the femoral component and the surrounding bone. The device is machined from crosslinked
polymethylmethacrylate copolymer and its function is to position the distal stem of the Modified
Profile Hip Femoral Prosthesis within the medullary canal of the proximal femur. The spacer
Intended use of the device	The Modified Profile Hip PMMA Spacer is intended for use with the Modified Profile Hip when it
is implanted as a cemented prosthesis in cemented hip replacement.
Indications for use	The Modified Profile Hip PMMA Spacer is indicated for use in cemented hip replacement.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Non-clinical testing is provided to support the conditional safety of the Modified Profile Hip PMMA Spacer in the MR environment, including assessment of;
Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.

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132

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Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	Apex Hole Eliminator PS
Common or usual name	Acetabular Cup Apical Hole Plug
Classification name	21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3358
Product Code(s)	LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented.

134

Legally marketed device(s) to which	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
equivalence is claimed	K963309 – Apex Hole Eliminator PS
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The Apex Hole Eliminator is a plug with machined threads having standard tolerances. The device
locks into the acetabular cup by means of a taper on the trailing edge of the component. This
taper is designed to seat on the leading edge of the apical hole of the cup, preventing the hole
plug from being screwed through the apical hole. When seated, the front or inside surface of the
Apex Hole Eliminator PS sits flush with the concave inner surface of the metal shell of the
	acetabular cup thereby avoiding deformation or wear of the UHMWPe liner against the edges of
the hole plug.
Intended use of the device	The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc
series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without
bone cement. It can be used after insertion of the acetabular cup in a cementless technique once
the cup is well seated to prevent movement of blood or particles from behind the shell through
the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to
prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides
support of the polyethylene liner utilized in the metal shell, assuring full, congruent,
uninterrupted support of the liner within the shell and eliminating the potential of cold flow of
the liner into the apical hole of the metal shell.
Indications for use	The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc
series two-piece (metal shell and UHMWPe liner) acetabular cups. It is intended for use in
Duraloc cups implanted with or without bone cement.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
	Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
	There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
	Non-clinical testing is provided to support the conditional safety of the Apex Hole Eliminator PS
in the MR environment, including assessment of;
	Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07)
	The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy.

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137

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	J-Fx Cerclage System
Common or usual name	Cerclage Fixation Device
Classification name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3030
Product Code(s)	LRN: Wire, Surgical
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIM™ Revision Hip System
	K971682 - J-Fx Cerclage System
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
	Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	The J-Fx Cerclage System consists of an implantable cable and crimp sleeve for use as an internal
cerclage fixation system in the management of fractures and reconstructive surgery. The cobalt
chromium multifilament cable can be used with the cobalt chromium crimp sleeve. The crimp
	sleeve is secured to the tensioned cable using a specially designed crimping instrument. The cable
and sleeve are available either in stainless steel or cobalt-chromium alloy.
Intended use of the device	The J-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopedic
repairs. These include procedures such as: reinforcement of bone; reattachment of the greater
trochanter; fixation of long bone fractures with grafting; and fixation of patellar fractures.
Indications for use	The J-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopedic
repairs. These include procedures such as: reinforcement of bone; reattachment of the greater
trochanter; fixation of long bone fractures with grafting; and fixation of patellar fractures.
Substantial Equivalence	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
Additionally, in order to harmonize with International and EU labeling requirements, the labeling
of subject devices which are sold Internationally will be further updated to also include a new
Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and
can be discarded by the end user. The labeling will also be updated to include a material code
with corresponding material descriptions.
There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices.
Non-clinical testing is provided to support the conditional safety of the J-Fx Cerclage System in the MR environment, including assessment of;
Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07)
The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy.

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141

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg
Ringaskiddy
Co. Cork
Ireland
Phone number	(+44) 7834974433
Fax number	N/A
Establishment Registration Number	3015516266
Name of contact person	Jennifer Hill
Date prepared	13th December 2023
Name of device
Trade or proprietary name	S-ROM™ Hip System Locking Plug
S-ROM™ Screws
Common or usual name	Locking Plug
Classification name	21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis.
Class	II
Classification panel	87 Orthopedics
Regulation	Class II - 21 CFR 888.3350
Class II - 21 CFR 888.3358
Product Code(s)	JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented.
LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented.
Legally marketed device(s) to which
equivalence is claimed	Primary Predicate – K102080 – RECLAIMTM Revision Hip System
K963206 - S-ROMTM Hip System Locking Plug
K951000 - S-ROMTM Screws
Reason for 510(k) submission	DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and
is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries.
There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices.
Device description	S-ROMTM Hip System Locking Plug
The Locking Plug consists of a head and body. The head has both internal threading and external
sections (barbs). The internal threading allows attachment of the insertion tool to the Locking
Plug. The body is cylindrical with an external lip. Both the external serrations of the head and the
	lip of the Locking Plug body aid in resisting disengagement of the Locking Plug from the shell/liner
assembly. The Locking Plug is available in both 3.5mm and 5.0mm sizes.

	S-ROM™ Screws
	The S-ROM™ Screws are available in a choice of sizes and are made of anodized titanium alloy
(Ti-Al6-V4/TiO2) and ultrahigh molecular weight polyethylene (UHMWPE).
	The use of orthopedic screws provides the orthopedic surgeon a means of ancillary bone fixation
in reconstructive surgeries. These implants are intended to provide additional stability to
implanted orthopedic devices and are NOT intended to replace normal body structure or bear the
weight of the body in the presence of incomplete bone healing.
Intended use of the device	Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components.
Indications for use	Total hip arthroplasty is indicated for total hip replacement in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis,
rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Bundled 510(k) Premarket Notification to expand the labeling
for the DePuy Hip Portfolio of Implants, which includes Hip Stems, Acetabular Shells and Liners,
Femoral Heads, and Hip Components, to provide updated information regarding the MRI
compatibility of its devices. A program of MRI Safety Evaluation testing has been carried out and |
| is reported within the 510(k), and appropriate amends have been made to the product labels
and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients.
At the same time as making these labeling updates in relation to MRI compatibility, DePuy will
take the opportunity to standardize language and symbols used across its legacy devices for
consistency, including the use of new internationally recognized symbols with corresponding
updated symbols glossaries. | |
| There is no change to the indications, intended use, safety, fit, form or technological
characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the S-ROMTM Hip System
Locking Pin and S-ROMTM Screws in the MR environment, including assessment of; | |
| Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the
MR environment under specific MR conditions of use, raise no new questions of safety or
efficacy. | |

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143

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Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

Limin Sun S

FDA IFU FORMS 3381

HIP STEMS FDA IFU FORMS 3381

510(k) Number (if known) K942370/K961619

Indications for Use (Describe)

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510(k) Number (if known)

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Indications for Use (Describe)

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510(k) Number (if known) K953703/K030979/K060581

Indications for Use (Describe)

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510(k) Number (if known)

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ACETABULAR PRODUCTS FDA IFU FORMS 3381

Device Name BI-MENTUM ALTRX DUAL MOBILITY LINERS

Indications for Use (Describe)

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510(k) Number (if known)

Device Name

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510(k) Number (if known)

Device Name

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FEMORAL HEADS FDA IFU FORMS 3381

510(k) Number (if known)

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Indications for Use (Describe)

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INDICATIONS - TOTAL HIP PROSTHESIS

INDICATIONS - HEMI-HIP PROSTHESIS

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COMPONENTS FDA IFU FORMS 3381

Device Name

Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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Indications for Use (Describe)

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510(k) Number (if known) K963206, K951000

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