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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankyloses.

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 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 hip hemi-arthroplasty.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document is for a medical device (hip prosthesis) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, such as MRMC studies, reader improvements, AI-specific ground truth, and training sets, are not applicable.

The submission is a 510(k) for the DePuy Corail AMT Hip Prosthesis, seeking substantial equivalence to already marketed predicate devices. The reason for the submission is a change in manufacturing and sterilization facility and a slight modification to packaging. The core device design, principle of operation, and materials remain the same as the predicate devices.

Acceptance Criteria and Device Performance (for a Hip Prosthesis)

Since this is a non-AI medical device, the "acceptance criteria" are related to established standards for biocompatibility, sterility, and coating characteristics, rather than diagnostic or analytical performance metrics.

Acceptance Criterion (Standard/Test)	Reported Device Performance (Compliance/Result)
Biological Safety (per ISO 10993-1) "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"	Demonstrated. (Implied compliance with the standard)
Sterilization Validation (per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013)	Validated. (Implied compliance with the standard for gamma sterilization)
Characterization Testing of Hydroxyapatite Coating (per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant")	Characterized. (Implied compliance with FDA guidance for HA coating properties)
Substantial Equivalence (Overall Conclusion)	The subject device is substantially equivalent to the predicate DePuy Corail AMT Hip Prosthesis products (K042992, K070554, K093736, K123991, K173960).

Study Details (Not applicable for an AI device in this context)

Since the provided document is for a physical medical device (hip prosthesis) and not an AI/SaMD, most of the requested fields related to AI performance are not available or applicable.

Sample size used for the test set and the data provenance:
- Not Applicable (N/A) for AI/SaMD. For this physical device, "test sets" would refer to samples used in engineering and biological testing (e.g., specific hip prosthesis components tested for strength, coating adherence, sterility). The document does not specify the number of units tested for each non-clinical test, nor does it detail data provenance beyond the device's manufacturing origin (Ireland).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A for AI/SaMD. Ground truth as defined for AI is not relevant here. For a physical medical device, "ground truth" might refer to established physical properties or biological responses, which are determined by standardized testing methods and scientific consensus, not expert consensus on interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A for AI/SaMD. Adjudication methods are typically used in clinical studies or human-reader performance evaluations, which are not detailed for this non-clinical submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a physical hip prosthesis, not an AI system. No MRMC study was conducted or is relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical hip prosthesis, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A for AI/SaMD. For the physical device, the "ground truth" for non-clinical tests would be defined by the specifications of the standards themselves (e.g., a material is "biocompatible" if it passes ISO 10993 tests, a sterilization process is "validated" if it meets the sterility assurance level (SAL) defined by ISO 11137). There is no "pathology" or "outcomes data" specifically mentioned for establishing "ground truth" in this non-clinical submission.
The sample size for the training set:
- N/A. This is a physical hip prosthesis, not an AI system, so there is no "training set."
How the ground truth for the training set was established:
- N/A. As there is no training set for an AI system, this question is not applicable.

Summary

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November 26, 2019

DePuy Orthopaedics, Inc. % Susan Mullane Regulatory Affairs Project Leader DePuy (Ireland) Loughbeg, Ringaskiddy CORK, P43ED82 IRELAND

Re: K192946

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 17, 2019 Received: October 18, 2019

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.

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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.

for

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

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Indications for Use

510(k) Number (if known) K192946

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 dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface

replacement arthroplasty, or total hip replacement.

Certain cases of ankyloses.

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 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 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 Ltd.
Address	Loughbeg,
	Ringaskiddy,
	Co.Cork, Ireland
Phone number	00 353 21 4914110
Fax number	N/A
Establishment Registration #	9616671
Name of contact person	Susan Mullane
Date prepared	15 October 2019
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 ornonporous uncemented prosthesisHip joint femoral (hemi-hip) metallic cemented or uncementedprosthesisHip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.5535, 888.3360, 888.3390
Product Code(s)	LZO, MEH, KWL, KWY
Legally marketed device(s)to which equivalence isclaimed	DePuy Corail AMT Hip Prosthesis (K042992, K070554, K093736,K123991, K173960)
Reason for 510(k)submission	The purpose of this submission is to support the manufacturing andsterilization of the subject, Hydroxyapatite (HA) coated DePuy CorailAMT Hip Prosthesis components at an alternate manufacturing andsterilization facility. The packaging has been slightly modified. Thereare no other modifications associated with this product in comparisonwith the currently marketed predicate DePuy Corail AMT HipProsthesis – the predicate and proposed devices share the same intendeduse, product design, principle of operation, and materials.
Device description	The DePuy Corail AMT hip stem family are manufactured fromforged titanium alloy (Ti6Al4V) and plasma-sprayed with ahydroxyapatite (HA) coating for bone fixation. The stem consists of awide range of stem neck designs and sizes allowing an accurateanatomical match for each patient. Corail AMT stems are availablewith or without a collar, with various neck angles, and with variousneck 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 thefollowing conditions:A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, rheumatoid arthritis, or congenital hip dysplasia.1. Avascular necrosis of the femoral head.2. Acute traumatic fracture of the femoral head or neck.3. Failed previous hip surgery including joint reconstruction,internal fixation, arthrodesis, hemi-arthroplasty, surfacereplacement arthroplasty, or total hip replacement.
	4. Certain cases of ankyloses.
	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 hemi-arthroplasty.
	HA coated stems of the Corail Hip system are indicated for cementless use only.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE
PREDICATE DEVICE
Characteristics	SubjectDevice:DePuy CorailAMT HipProsthesis	PredicateDevice:DePuy CorailAMT HipProsthesis(K123991)	PredicateDevice:DePuy CorailAMT HipProsthesis(K123991)	ReferenceDevice:DePuy CorailHip System,Revision Stem(K093736)	PredicateDevice:DePuy CorailAMT HipProsthesis(K070554)	PredicateDevice:DePuy CorailAMT HipProsthesis(K042992)
Intended Use	Total HipArthroplasty,Hemi-HipArthroplasty	Same	Same	Total HipArthroplasty	Total HipArthroplasty	Total HipArthroplasty
Material	Ti6Al4V withplasma sprayedHA coating	Same	Same	Same	Same	Same
Fixation	Uncemented	Same	Same	Same	Same	Same
Sterile Method	Gamma	Same	Same	Same	Same	Same
Packaging	Inner Pouch andouter PETGblister withTyvek peel lid	Double PETGblister withTyvek peel lid	Double PETGblister withTyvek peel lid	Double PETGblister withTyvek peel lid	Double PETGblister withTyvek peel lid	Double PETGblister withTyvek peel lid

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Shelf Life	5 years	Same	Same	Same	Same	Same
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
THE FOLLOWING TESTS WERE PERFORMED ON THE DEPUY CORAIL AMT HIP PROSTHESIS TO DEMONSTRATESUBSTANTIAL EQUIVALENCE OF SAFETY AND EFFICACY WITH THE PREDICATE DEVICES:
•	BIOLOGICAL SAFETY PER ISO 10993-1 "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1:EVALUATION AND TESTING".
•	STERILIZATION VALIDATION PER AAMI ANSI ISO 11137-1: 2006/(R)2010 AND AAMI ANSI ISO 11137-2: 2013
•	CHARACTERIZATION TESTING OF HYDROXYAPATITE COATING AS RECOMMENDED PER FDA GUIDANCE:"510(K) INFORMATION NEEDED FOR HYDROXYAPATITE COATED ORTHOPEDIC IMPLANT”
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCEAND/OR OF CLINICAL INFORMATION
NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
THE SUBJECT DEPUY CORAIL AMT HIP PROSTHESIS PRODUCTS ARE SUBSTANTIALLY EQUIVALENT TO THEPREDICATE DEPUY CORAIL AMT HIP PROSTHESIS PRODUCTS ((K042992, K070554, K093736, K123991, K173960))

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.