(27 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 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.
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.
This document pertains to a 510(k) premarket notification for a medical device, the DePuy Corail AMT Hip Prosthesis. The purpose of this submission, as stated, is to extend the approved shelf life of the device from 5 years to 10 years.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to demonstrating that the device remains safe and effective for the extended shelf life, specifically focusing on the integrity of the Hydroxyapatite (HA) coating after extended aging.
Based on the provided text, while the document confirms the device's substantial equivalence for its extended shelf life, it does not contain the detailed information typically found in an AI/software as a medical device (SaMD) study regarding performance criteria, sample sizes, expert qualifications, or multi-reader studies. The studies mentioned are primarily non-clinical bench tests focused on material properties after aging.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document mentions specific non-clinical tests performed, implying that the acceptance criteria are related to meeting the standards outlined in those test methods. However, the exact quantitative acceptance criteria (e.g., "HA coating adhesion strength > X MPa") and the numerical results of the device performance against those criteria are not explicitly reported in the text. The document only confirms that these tests were performed and conclude substantial equivalence.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Inferred from conclusion) |
|---|---|
| Meeting specifications for HA coating characteristics on shelf-aged product per: - ISO-13779-3 (Chemical analysis, crystallinity, phase purity) - ASTM F1854 (Stereological evaluation of porous coatings) - ASTM E2109 (Area percentage porosity in thermal sprayed coatings) | The tests were performed and supported the conclusion of substantial equivalence for the 10-year shelf life, implying the device met the required specifications for HA coating integrity after extended aging. |
2. Sample sizes used for the test set and the data provenance
- Sample sizes for the test set: Not specified in the provided document. The text states "the following tests were performed," but does not mention the number of units tested.
- Data provenance: The tests were performed on "shelf-aged product." The country of origin of the data is not specified, but the applicant is DePuy (Ireland). The studies are inherently prospective in the sense that they are designed to simulate future aging, but performed in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts and qualifications: Not applicable to this type of non-clinical bench testing. Ground truth for these tests is established by adhering to standardized test methods (ISO, ASTM) and using calibrated laboratory equipment and trained technicians/engineers. There is no human interpretation of images or clinical outcomes that would require expert consensus.
4. Adjudication method for the test set
- Adjudication method: Not applicable to this type of non-clinical bench testing. The results are quantitative measurements against established standards, not subjective interpretations requiring 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
- MRMC study: No. This device is a hip prosthesis, not an AI or imaging device. Therefore, MRMC studies are not relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: No. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of ground truth: For the non-clinical tests, the "ground truth" is defined by the standardized methodologies and specifications outlined in ISO and ASTM standards. For example, the ground truth for HA coating crystallinity would be the measurement obtained by a specified analytical technique (e.g., X-ray diffraction) that meets the criteria of ISO-13779-3.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device does not involve machine learning or a "training set." The tests conducted are to confirm the physical properties of the device over its extended shelf life.
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable. As there is no training set involved, this question is not relevant.
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November 19, 2020
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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.
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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.
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)
Device Name
DePuy Corail AMT Hip Prosthesis
Indications for Use (Describe)
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 | ||||||
| EstablishmentRegistration Number | 9616671 | ||||||
| Name of contact person | Susan Mullane | ||||||
| Date prepared | September 2020 | ||||||
| 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 888.5535, 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 5years to 10 years | ||||||
| Device description | The DePuy Corail AMT hip stem family are manufactured from forged titaniumalloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating forbone fixation. The stem consists of a wide range of stem neck designs and sizesallowing an accurate anatomical match for each patient. Corail AMT stems are |
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| 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: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. |
| 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. Avascular necrosis of the femoral head.3. Non-union of femoral neck fractures.4. Certain high subcapital and femoral neck fractures in the elderly.5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.6. 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 DEVICECOMPARED TO THE PREDICATE DEVICE | ||||
|---|---|---|---|---|
| Characteristics | Subject Device:DePuy CorailAMT HipProsthesis | Predicate Device:DePuy CorailAMT HipProsthesis(K192946,K173960) | Predicate Device:DePuy CorailAMT HipProsthesis(K070554,K093736,K123991) | PrimaryPredicateDePuy CorailAMT HipProsthesis(K042992) |
| Intended Use | Total HipArthroplasty | Total HipArthroplasty | Total HipArthroplasty | Total HipArthroplasty |
| Material | Titanium Alloy(Ti6Al4V) withplasma sprayedHA coating | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating | Titanium Alloy(Ti6Al4V) withplasma sprayed HAcoating | Titanium Alloy(Ti6Al4V) withplasma sprayedHA coating |
| Fixation | Uncemented | Uncemented | Uncemented | Uncemented |
| Sterile Method | Gamma | Gamma | Gamma | Gamma |
| Packaging | Nylon InnerPouch andouter PETGblister withTyvek peel lid | Nylon Inner Pouchand outer PETGblister with Tyvekpeel lid | Double PETGblister with Tyvekpeel lid | Double PETGblister withTyvek peel lid |
| Shelf life | 10 Years | 5 Years | 5 Years | 5 Years |
| PERFORMANCE DATASUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | ||||
| The following tests were performed in the DePuy Corail AMT Hip Prosthesis to demonstratesubstantial 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 andOcharacterization of crystallinity and phase purity.ASTM F1854 - Standard test method for stereological evaluation of porous coatingsOon medical implants.ASTM E2109 - Standard test methods for determining area percentage porosity inOthermal sprayed coatings.SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATIONNo clinical tests were conducted to demonstrate substantial equivalence. | ||||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
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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).
§ 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.