(28 days)
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 hemi-arthroplasty.
HA coated stems of the Corail Hip system are indicated for cementless use only.
The DePuy Corail AMT hip stem family are manufactured from forged titanium alloy (Ti6A14V) 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.
The provided text is a 510(k) summary for the DePuy Corail AMT Hip Prosthesis. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel device performance through extensive clinical trials or AI/ML studies.
Therefore, many of the requested criteria (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and details about training sets for AI devices) are not applicable to this type of regulatory submission as it does not involve an AI/ML device or a comparative effectiveness study with human readers.
However, the document does describe non-clinical tests conducted to support modifications to an existing device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the format of a typical clinical trial or AI device validation study with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests performed to demonstrate product specifications and safety for changes introduced (new manufacturing site, increased shelf life, alternate manufacturing process). The "performance" is demonstrated by conforming to these established testing standards.
I will attempt to structure this into a table based on the non-clinical tests mentioned.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Goal/Outcome) |
|---|---|
| HA Coating Characterization (per FDA Guidance 1997) | Supported addition of alternate HA coating site; full suite of characterization and testing completed. |
| Body Fatigue Testing (per ISO 7206-4) | Supported addition of alternate HA coating site; results demonstrate conformational design verification. |
| Neck Fatigue Testing (per ISO 7206-6) | Supported addition of alternate HA coating site; results demonstrate conformational design verification. |
| Visual Inspection (per ASTM F1886-16) | Supported increase in shelf life; integrity of seals confirmed. |
| Dye Leak Test (per ASTM F1929-15) | Supported increase in shelf life; seal leaks in porous medical packaging confirmed absent. |
| Seal Strength Test (per ASTM F88/F88M-15) | Supported increase in shelf life; strength of flexible barrier materials confirmed. |
| HA Coating Testing (per ISO-13779-2) on shelf-aged product | Supported increase in shelf life; characteristics of thermally sprayed HA coatings maintained after aging. |
| HA Coating Testing (per ISO-13779-3) on shelf-aged product | Supported increase in shelf life; chemical analysis, crystallinity, and phase purity of HA coatings maintained after aging. |
| HA Coating Testing (per ASTM F1854) on shelf-aged product | Supported increase in shelf life; stereological evaluation of porous coatings maintained after aging. |
| HA Coating Testing (per ASTM E2109) on shelf-aged product | Supported increase in shelf life; area percentage porosity in thermal sprayed coatings maintained after aging. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test. These tests typically involve a limited number of device samples or components subjected to specific mechanical, chemical, or aging conditions. There is no "data provenance" in terms terms of country of origin for patients, as no clinical data was used for this specific 510(k) submission. These are laboratory-based, non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for non-clinical engineering tests is established by documented industry standards (e.g., ISO, ASTM) and internal quality control processes, not by expert consensus in a medical diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring medical adjudication was used.
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 not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the relevant ISO and ASTM standards cited. For example, a seal strength test has a numerical minimum requirement for a "pass."
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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January 6, 2022
Image /page/0/Picture/1 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.
DePuy Orthopaedics Inc. % Paul Shin Project Lead, Regulatory Affairs DePuy (Ireland) Loughbeg. Ringaskiddy Cork, Cork P43ED82 Ireland
Re: K213839
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: December 8, 2021 Received: December 9, 2021
Dear Paul Shin:
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
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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,
Limin Sun, Ph.D. Acting 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) K213839
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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2023 |
See PRA Statement below.
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510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedic DriveWarsaw, IN 46852 |
| Phone number | (574) 404-8348 |
| Fax number | N/A |
| EstablishmentRegistration Number | 1818910 |
| Name of contact person | Paul Shin |
| Date prepared | December 7, 2021 |
| Name of device | |
| Trade or proprietaryname | DePuy Corail AMT Hip Prosthesis |
| Common or usualname | Uncemented hip prosthesis |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesisHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesisHip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353, 888.3360, 888.3390 |
| Product Code(s) | LZO, MEH, KWL, KWY |
| Legally marketeddevice(s) to whichequivalence is claimed | DePuy Corail AMT Hip Prosthesis (K042992, K093736, K190344, K192946,K203167). |
| Reason for 510(k)submission | The purpose of this submission is to implement the following:• Addition of DePuy Ireland as a hydroxyapatite (HA) coating site.• Increase in the shelf life of specific product codes of Corail AMT Hipstems from 5 years to 10 years.• Addition of an alternate manufacturing process flow. |
| Device description | The DePuy Corail AMT hip stem family are manufactured from forged titaniumalloy (Ti6A14V) 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 thedevice | Total hip arthroplasty and hemi-hip arthroplasty |
| Indications for use | Total hip replacement or hip arthroplasty is indicated in the followingconditions: |
| 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, internalfixation, arthrodesis, hemi-arthroplasty, surface replacementarthroplasty, or total hip replacement. | |
| 5. Certain cases of ankylosis. | |
| Partial hip replacement or hip hemi-arthroplasty is indicated in thefollowing conditions: | |
| 1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation. | |
| 2. Fracture dislocation of the hip that cannot be appropriately reducedand 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 theacetabulum does not require replacement. | |
| 7. Pathology involving only the femoral head/neck and/or proximalfemur that can be adequately treated by hip hemi-arthroplasty. | |
| HA coated stems of the Corail Hip system are indicated for cementless useonly. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICECOMPAREDTO THE PREDICATE DEVICE | ||||
|---|---|---|---|---|
| Characteristics | Subject DeviceDePuy CorailAMTHip ProsthesisDePuy CorailRevisionHip Prosthesis | PrimaryPredicateDePuy CorailAMTHip Prosthesis(K042992) | AdditionalPredicatesDePuy CorailAMT HipProsthesis(K203167,K190344) | AdditionalPredicatesDePuy CorailRevisionHip Prosthesis(K203167,K192946,K093736) |
| Intended Use | Total HipArthroplasty | Total HipArthroplasty | Total HipArthroplasty | Total HipArthroplasty |
| Material | Titanium Alloy(Ti6Al4V) withplasma sprayedHA coating | Titanium Alloy(Ti6Al4V) withplasma sprayedHA coating | Titanium Alloy(Ti6Al4V) withplasma sprayedHA coating | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating |
| Fixation | Uncemented | Uncemented | Uncemented | Uncemented |
| SterilizationMethod | Gamma | Same | Same | Same |
| Packaging | Nylon Inner Pouchand outer PETGblister with Tyvekpeel lid | Same | Same | Same |
| Shelf life | 10 Years | 5 Years | 10 Years | 10 Years |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE |
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The following tests were performed on the subject devices to demonstrate substantial equivalence of safety and effectiveness with the predicate devices:
- HA coating characterization supporting addition of alternate HA coating site
- Completed the full suite of HA coating characterization and testing per FDA Guidance O 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants 1997
- Conformational design verification testing supporting addition of alternate HA coating site ●
- Body fatigue testing per ISO 7206-4 O
- Neck fatigue testing per ISO 7206-6 о
- Packaging stability testing supporting increase in shelf life ●
- Visual inspection per ASTM F1886-16: Standard test method for determining O integrity of seals for flexible packaging by visual inspection
- O Dye Leak per ASTM F1929-15: Standard test method for detecting seal leaks in porous medical packaging by dye penetration
- Seal strength per ASTM F88/F88M-15: Standard test method for seal strength of o flexible barrier materials
- HA coating testing on shelf-aged product per ●
- ISO-13779-2: Implants for surgery Hydroxyapatite Part 2: Thermally Sprayed o coatings of Hydroxyapatite
- 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 DePuy Corail AMT Hip Prosthesis devices are substantially equivalent to the predicate devices (K042992, K093736, K190344, K192946, K203167).
§ 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.