K Number

Device Name

DePuy Corail AMT Hip Prosthesis

Manufacturer

DePuy Orthopaedics Inc.

Date Cleared

2020-11-19

(27 days)

Product Code

LZO KWL KWY MEH

Regulation Number

888.3353

Intended Use

Total hip replacement or hip arthroplasty is indicated in the following conditions. 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dvsplasia. 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, hem-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankvloses. Partial hip replacement or hip hemi-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 hip hemiarthroplasty. HA coated stems of the Corail Hip system are indicated for cementless use only.

Device Description

The DePuy Corail AMT hip stem family are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles, and with various neck offsets.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K042992, K192946, K173960, K070554, K093736, K123991

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hip implant and its materials, indications, and testing. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes.
The device is a hip stem used in total hip replacement or partial hip replacement procedures to alleviate pain and disability caused by various conditions, which directly addresses a health problem by replacing a diseased or damaged body part.

Diagnostic

No.
The device described is a hip stem/prosthesis, which is an implant used in hip replacement surgery to treat conditions like arthritis or fractures. It is a therapeutic device, not a diagnostic one. Its purpose is to replace or assist a damaged joint, not to identify or diagnose a disease or condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is a hip stem manufactured from forged titanium alloy and plasma-sprayed with a hydroxyapatite coating, indicating it is a physical implant, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
Device Description and Intended Use: The provided information clearly describes a total or partial hip replacement prosthesis. This is an implantable medical device used to surgically replace a damaged hip joint. It is used in the body, not to test samples from the body.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.

Therefore, based on the provided information, the DePuy Corail AMT hip stem family is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Partial hip replacement or hip hemi-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 hip hemiarthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

Product codes

LZO, MEH, KWL, KWY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip, femoral head, femoral neck, 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

No clinical tests were conducted to demonstrate substantial equivalence.
Non-clinical tests performed:
HA coating testing on shelf-aged product per:

ISO-13779-3: Implants for surgery - Hydroxyapatite Part 3: Chemical analysis and characterization of crystallinity and phase purity.
ASTM F1854 - Standard test method for stereological evaluation of porous coatings on medical implants.
ASTM E2109 - Standard test methods for determining area percentage porosity in thermal sprayed coatings.

Key Metrics

Not Found

Predicate Device(s)

K042992, K192946, K173960, K070554, K093736, K123991

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

November 19, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol features a stylized depiction of a caduceus, a symbol associated with medicine and healthcare. To the right of the symbol, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in a clear, sans-serif font, with "FDA" in a blue square.

DePuy Orthopaedics Inc. % Susan Mullane Regulatory Affairs Manager DePuy (Ireland) Loughbeg, Ringaskiddy Cork, Co. Cork, Munster P43ED82 Ireland

Re: K203167

Trade/Device Name: DePuy Corail AMT Hip Prosthesis 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: LZO, MEH, KWL, KWY Dated: October 20, 2020 Received: October 23, 2020

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.

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 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).

Sincerely.

Vesa Vuniqi 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

Indications for Use

510(k) Number (if known)

K203167

Device Name

DePuy Corail AMT Hip Prosthesis

Indications for Use (Describe)

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

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

Partial hip replacement or hip hemi-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 hip hemiarthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

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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510(K) SUMMARY

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

Submitter Information
Name	DePuy (Ireland)
Address	Loughbeg,
Ringaskiddy,
	Co.Cork, Ireland
Phone number	00 353 21 4914110
Fax number	N/A
Establishment
Registration Number	9616671
Name of contact person	Susan Mullane
Date prepared	September 2020
Name of device
Trade or proprietary
name	DePuy Corail AMT Hip Prosthesis
Common or usual
name	Uncemented hip prosthesis
Classification name	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
uncemented prosthesis
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.5535, 888.3360, 888.3390
Product Code(s)	LZO, MEH, KWL, KWY
Legally marketed	DePuy Corail AMT Hip Prosthesis (K042992, K070554, K093736, K123991,
K173960, K192946)
Reason for 510(k)
submission	The purpose of this submission is to extend the current approved shelf life of 5
years to 10 years
Device description	The DePuy Corail AMT hip stem family are manufactured from forged titanium
alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for
bone fixation. The stem consists of a wide range of stem neck designs and sizes
allowing an accurate anatomical match for each patient. Corail AMT stems are

	available with or without a collar, with various neck angles, and with various neck offsets.
Intended use of the device	Total hip arthroplasty and hemi-hip arthroplasty
Indications for use	Total hip replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis. |
| | Partial hip replacement or hip hemi-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.
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 hip hemi-arthroplasty. |
| | HA coated stems of the Corail Hip system are indicated for cementless use only. |

| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE

COMPARED TO THE PREDICATE DEVICE
Characteristics	Subject Device:
DePuy Corail
AMT Hip
Prosthesis	Predicate Device:
DePuy Corail
AMT Hip
Prosthesis
(K192946,
K173960)	Predicate Device:
DePuy Corail
AMT Hip
Prosthesis
(K070554,
K093736,
K123991)	Primary
Predicate
DePuy Corail
AMT Hip
Prosthesis
(K042992)
Intended Use	Total Hip
Arthroplasty	Total Hip
Arthroplasty	Total Hip
Arthroplasty	Total Hip
Arthroplasty
Material	Titanium Alloy
(Ti6Al4V) with
plasma sprayed
HA coating	Titanium Alloy
(Ti6Al4V) with
plasma sprayed HA
coating	Titanium Alloy
(Ti6Al4V) with
plasma sprayed HA
coating	Titanium Alloy
(Ti6Al4V) with
plasma sprayed
HA coating
Fixation	Uncemented	Uncemented	Uncemented	Uncemented
Sterile Method	Gamma	Gamma	Gamma	Gamma
Packaging	Nylon Inner
Pouch and
outer PETG
blister with
Tyvek peel lid	Nylon Inner Pouch
and outer PETG
blister with Tyvek
peel lid	Double PETG
blister with Tyvek
peel lid	Double PETG
blister with
Tyvek peel lid
Shelf life	10 Years	5 Years	5 Years	5 Years
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE
The following tests were performed in the DePuy Corail AMT Hip Prosthesis to demonstrate
substantial equivalence of safety and efficacy with the predicate devices:
HA coating testing on shelf-aged product per -
●
ISO-13779-3: Implants for surgery - Hydroxyapatite Part 3: Chemical analysis and
O
characterization of crystallinity and phase purity.
ASTM F1854 - Standard test method for stereological evaluation of porous coatings
O
on medical implants.
ASTM E2109 - Standard test methods for determining area percentage porosity in
O
thermal sprayed coatings.
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 device DePuy Corail AMT Hip Prosthesis products are substantially equivalent to the predicate DePuy Corail AMT Prosthesis products (K042992, K070554, K093736, K123991, K173960, K192946).