K Number
K232556
Device Name
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
Manufacturer
Date Cleared
2023-09-20

(28 days)

Product Code
Regulation Number
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The TriFlange Hip Prosthesis is indicated in the following conditions: 1. Where bones loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications. The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during 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. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.
Device Description
The 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating.
More Information

DePuy TriFlange II Acetabular Cup System (K040383), DePuy 3D Additive TriFlange Acetabular Cup (K201348)

Not Found

No
The summary describes a hip prosthesis and its manufacturing process, with no mention of AI or ML technology.

Yes
The device is an acetabular prosthesis used in total hip arthroplasty to reduce pain and increase patient mobility by replacing a damaged hip joint, which is a therapeutic purpose.

No
The device is a prosthesis intended for total hip arthroplasty, which is a treatment, not a diagnostic procedure.

No

The device description clearly states it is a physical acetabular cup system manufactured via additive manufacturing and CNC machining, intended for surgical implantation. It is a hardware device, not software.

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

Here's why:

  • Intended Use: The intended use clearly states that the device is a hip prosthesis used to resurface the acetabular socket during total hip arthroplasty. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description details a physical implantable device made of titanium, designed to replace a damaged hip joint. It does not describe any reagents, instruments, or software used for testing biological samples.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.

The device is a medical device, specifically a surgical implant, used for treatment (replacing a damaged joint) rather than diagnosis.

N/A

Intended Use / Indications for Use

The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

The TriFlange Hip Prosthesis is indicated in the following conditions:

  1. Where bones loss is present in the acetabular region

  2. Pelvic discontinuities

Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.

The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during 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.

Total hip replacement is indicated in the following conditions:

  1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

  5. Certain cases of ankylosis.

Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.

Product codes (comma separated list FDA assigned to the subject device)

LPH, MEH

Device Description

The 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Acetabular socket (Hip joint)

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)

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

  • HA Powder characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
  • HA Coating thickness per ASTM F1854.
  • HA Coating characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
  • Tensile Adhesion testing per ASTM F1147-05.
  • Shear Adhesion testing per ASTM F1044-05.
  • Rotating Beam Fatigue per ASTM F1160.
  • Solubility of HA particles before and after HA coating
  • Dissolution of HA particles before and after HA coating per ASTM F1926-10
  • FTIR analysis of HA powder before and after HA coating.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject devices are substantially equivalent to the predicate DePuy 3D Additive TriFlange Acetabular Cup (K201348) and DePuy TriFlange II Acetabular Cup System (K040383).

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

DePuy TriFlange II Acetabular Cup System (K040383), DePuy 3D Additive TriFlange Acetabular Cup (K201348)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

September 20, 2023

DePuy Ireland UC Susan Mullane Associate Director Regulatory Affairs Loughbeg, Ringaskiddy Cork, Ireland

Re: K232556

Trade/Device Name: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MEH Dated: August 23, 2023 Received: August 23, 2023

Dear Susan Mullane:

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 (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 located 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.

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.

1

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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).

Sincerely.

Limin Sun

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K232556

Device Name

DePuy 3D Additive TriFlange Acetabular Cup

Indications for Use (Describe)

The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.

The TriFlange Hip Prosthesis is indicated in the following conditions:

  1. Where bones loss is present in the acetabular region

  2. Pelvic discontinuities

Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.

|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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K232556

Device Name

DePuy TriFlange II Acetabular Cup System

Indications for Use (Describe)

The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during 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.

Total hip replacement is indicated in the following conditions:

  1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.

  5. Certain cases of ankylosis.

Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
NameDePuy Ireland UC
AddressLoughbeg, Ringaskiddy
Cork, IRELAND
Phone number35 (32) 149-14000
Fax number574- 371-4987
Establishment Registration
Number3015516266
Name of contact personSusan Mullane
Date prepared19th September 2023
Name of device
Trade or proprietary
nameDePuy 3D Additive TriFlange Acetabular Cup
DePuy TriFlange II Acetabular Cup System
Common or usual nameAcetabular cup
Classification nameHip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis
ClassII
Classification panel87 Orthopedics
Regulation21 CFR 888.3358, 888.3353
Product Code(s)LPH, MEH
Legally marketed device(s)
to which equivalence is
claimedDePuy 3D Additive TriFlange Acetabular Cup (K201348)
DePuy TriFlange II Acetabular Cup System (K040383) (Primary Predicate)
Reason for 510(k) submissionThe only change for this submission is that the HA coating process will be conducted at an alternate facility. All other process remain the same and within the same approved facility.
Device descriptionThe 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating.
Intended use of the deviceTotal hip arthroplasty
Indications for useDePuy 3D Additive TriFlange Acetabular Cup (K201348): The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The TriFlange Hip Prosthesis is indicated in the following conditions: 1. Where bones loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
DePuy TriFlange II Acetabular Cup System (K040383):
The system is intended to be used with modular liners to resurface the
acetabular socket in cementless application during 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.
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, hemi-arthroplasty, surface
replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
Porous-coated TriFlange Hip Prostheses are indicated for cement-less
applications.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
CharacteristicsSubject Device:
TriflangePredicate Device:
DePuy 3D Additive TriFlange
Acetabular Cup (K201348)Predicate Device:
DePuy TriFlange II Acetabular Cup
System (K040383)
Intended UseTotal Hip ArthroplastySameSame
MaterialThe Triflange acetabular shells, subject
of this submission, are manufactured
from titanium alloy (Ti6Al4V) for
surgical implant applications and are
coated with beaded porous coating and
plasma sprayed with hydroxyapatite
(HA), which are identical materials to
the predicate devices.
The HA Coating process will be
completed in an alternate site.Ti6Al4V with Porocoat, with and without
plasma sprayed HA coatingSame
FixationUncementedSameSame
Cup Sizes48mm OD to 66mm ODSameSame
Flange SizesPatient specificSameSame
Sterile MethodGammaSameSame

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PackagingDouble PETG blister with Tyvek peel lidSameSame
Shelf Life5 yearsSameSame

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

□ HA Powder characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
□ HA Coating thickness per ASTM F1854.
□ HA Coating characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
□Tensile Adhesion testing per ASTM F1147-05.
□Shear Adhesion testing per ASTM F1044-05.
□Rotating Beam Fatigue per ASTM F1160.
□ Solubility of HA particles before and after HA coating
□ Dissolution of HA particles before and after HA coating per ASTM F1926-10
□ FTIR analysis of HA powder before and after HA coating.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF

CLINICAL INFORMATION

No clinical tests were conducted to demonstrate substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The subject devices are substantially equivalent to the predicate DePuy 3D Additive TriFlange Acetabular Cup (K201348) and DePuy TriFlange II

Acetabular Cup System (K040383).