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.
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 Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.

AI/ML Overview

The provided document describes the Corail AMTTM Hip Prosthesis, an orthopaedic device. The submission is a 510(k) to expand the cleared indication for use to include hip hemi-arthroplasty surgical application.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria	Reported Device Performance
Material	Composition	Ti-6Al-4V	Ti-6Al-4V (Same as predicate)
Stem Surface	Coating for bone fixation	Plasma-sprayed with biocompatible hydroxyapatite (HA) coating	Plasma-sprayed with biocompatible hydroxyapatite (HA) coating (Same as predicate)
Compatible Femoral Heads	Types of heads accepted	Bipolar and Unipolar	Bipolar and Unipolar (Same as predicate)
Taper Design	Modular Taper	12/14 taper	12/14 taper (Same as predicate)
Placement	Method of implantation	Press Fit: Cementless	Press Fit: Cementless (Same as predicate)
Performance Data	Validation of taper/heads dimensional compatibility	Implied to perform acceptably for mechanical mating	Performed as "Validation of the taper/heads dimensional compatibility with Corail AMT Stems"
Performance Data	Fatigue Resistance	Implied to withstand anticipated physiological loads and cycles	Performed as "Fatigue Resistance tests for the Corail AMT Stems"
Clinical Equivalence (for expanded indication)	Safety and effectiveness for hip hemi-arthroplasty	Substantial equivalence to predicate devices and supported by existing clinical literature	Supported by a systematic literature review of Corail Hip System for femoral neck fractures, demonstrating no fundamental change in scientific technology and consistency with established safety and effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Non-clinical (Performance) Tests: The document does not specify the exact sample sizes (number of devices tested) for the "Validation of the taper/heads dimensional compatibility" or the "Fatigue Resistance tests." It only states that these tests were performed. Given the nature of these tests, they would typically involve a defined number of test articles to meet industry standards (e.g., ISO or ASTM standards for implant testing).
Clinical Evaluation: No new clinical tests were conducted. The clinical evaluation utilized a "systematic literature review of Corail Hip System for the treatment of femoral neck fractures." The provenance of the data in this systematic review would depend on the included studies, but the document does not provide details on country of origin or whether these studies were retrospective or prospective. It is a compilation of retrospective existing scientific literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on non-clinical performance testing and a literature review for clinical evaluation, not on a test set requiring expert ground truth for interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

5. 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

Not applicable. This is a medical device for hip arthroplasty, not an AI-based diagnostic or imaging device that would typically involve MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hip prosthesis, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Non-clinical (Performance) Tests: Ground truth for these tests is based on engineering specifications, material properties, and established test standards (e.g., demonstrating mechanical compatibility and fatigue life under simulated physiological conditions).
Clinical Evaluation: The "ground truth" for the clinical evaluation is based on the outcomes data and findings reported in the systematic scientific literature review regarding the safety and effectiveness of the Corail Hip System for femoral neck fractures, by extension supporting the expanded indications for hemi-arthroplasty.

8. The sample size for the training set

Not applicable. This is a medical device for hip arthroplasty, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device submission.

Summary

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K123991 (pg 1/3)

Section 5: 510 (k) Summary

As required by 21 CFR 807.92(c)

Sponsor	As required by 21 CFR 807.92(c)
Name	DePuy Orthopaedics France S.A.S.
Address	7 Allee Irene Joliot Curie bp256;Saint Priest Cedex, France 69801
Phone number	+33 4 72 79 27 27
Fax number	+33 4 72 79 28 38
EstablishmentRegistrationNumber	3003895575
Application Correspondent
Name	DePuy Orthopaedics, Inc.
Address	700 Orthopaedic DriveWarsaw. IN 46581
Phone number	(574)-372-7349
Fax number	(574) 371-4987
EstablishmentRegistrationNumber	1818910
Name ofcontact person	Alma Relja, RAC
Date prepared	December 19, 2012
Name of device
Trade orproprietaryname	Corail AMTTM Hip Prosthesis
Common orusual name	Hip Stem
Classificationname	Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesisHip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis; Class IIHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; Class II
Classification panel	87 - Orthopedics Branch, Division of General and Restorative Devices
Regulation	21 CFR 888.3390; 888.3353; 8888.3360
Product Code(s)	KWY, LZO, KWL
Legally marketeddevice(s) to whichequivalence isclaimed	Corail AMTTM Hip Prosthesis (K070554: K042992)MetaFix Femoral Stem for Hemi-Arthroplasty (K120362)Apex ARC Hip Stem (K113242; K111193)
Reason for 510(k)submission	Expand currently cleared Indication for Use to add hip hemi-arthroplasty surgicalapplication

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Device description	The Corail AMT Hip is a tapered stem available both collarless and collared. Thestems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with abiocompatible hydroxyapatite (HA) coating for bone fixation.The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with awide range of diameters. The compatible components for the hip hemi-arthroplastyapplication are bipolar heads cleared via 510(k) K812672 and unipolar heads clearedvia 510(k) K903084. Corail AMT stems are indicated for cementless use only.
Intended Use		Total Hip Arthroplasty and Hemi Hip Arthroplasty
Indications for Use		Total hip replacement or hip arthroplasty is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, 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 hipreplacement.5. Certain cases of ankylosis.Partial hip replacement or hip hemi-arthroplasty is indicated in the followingconditions:1. Acute fracture of the femoral head or neck that cannot be appropriatelyreduced and treated with internal fixation.2. Fracture dislocation of the hip that cannot be appropriately reduced andtreated 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 theacetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/or proximal femur thatcan 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
Characteristic	DePuy Orthopaedics CorailAMT™ Hip Prosthesis(subject device, predicatedevices: K070554; K042992)	MetaFix Femoral Stemfor Hemi-Arthroplasty(K120362)	Apex ARC Hip Stem(K113242 and K11193)
Material	Ti-6Al-4V	Same as Subject Device	Same as Subject Device
Stem Surface	plasma-sprayed with abiocompatible hydroxyapatite(HA) coating for bone fixation	Same as Subject Device	Same as Subject Device
CompatibleFemoral Heads	Bipolar and Unipolar	Same as Subject Device	Bipolar
Taper Design	12/14 taper	Same as Subject Device	Same as Subject Device
Placement	Press Fit: Cementless	Same as Subject Device	Same as Subject Device
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCEThe following non-clinical performance data is provided in this submission:

Validation of the taper/heads dimensional compatibility with Corail AMT Stems
. Fatigue Resistance tests for the Corail AMT Stems

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SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

No clinical tests have been performed for determination of substantial equivalence.

However, included in this submission is a clinical evaluation utilizing systematic literature review of Corail Hip System for the treatment of femoral neck fractures. This clinical evaluation of the subject device is based on an assessment of the risks and benefits associated with the use of the device through a systematic compilation of the relevant scientific literature currently available and a critical evaluation of the clinical literature identified.

The fundamental scientific technology of the Corail AMT Hip stem has not changed in order to expand the indications for use to add hip hemi-arthroplasty and utilize the compatible unipolar and bipolar heads. The safety and effectiveness of the subject Corail AMT Hip stem is adequately supported by the substantial equivalence information, materials information, review of clinical literature to support the modified indications for use and performance test data provided in this submission.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2013

DePuy France S.A.S % Ms. Alma Relja DePuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K123991

Trade/Device Name: Corail AMT" Hip Prosthesis Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY, LZO, KWL Dated: August 14, 2013 Received: August 15, 2013

Dear Ms. Relja:

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. 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 (reporting of medical

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Page 2 - Ms. Alma Relja

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson - S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510 (k) Number (if known); K123991 (pg 1/1)

Device Name: Corail AMT Hip Prosthesis

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

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

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.
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.
Degenerative arthritis involving only the femoral head in which the acetabulum does not 6. require replacement.
1. 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

Concurrence of Center for Devices and Radiological Health

Elizabeth L. Frank -S

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.