(28 days)
Not Found
No
The summary describes a hip implant device made of titanium alloy with a hydroxyapatite coating. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are focused on material properties and mechanical testing, not algorithmic performance.
Yes
This device (DePuy Corail AMT hip stem family) is a hip implant, used for total or partial hip replacement, which is a therapeutic intervention aimed at alleviating pain and restoring joint function.
No
The device description clearly states that it is a "DePuy Corail AMT hip stem family manufactured from forged titanium alloy (Ti6A14V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation." This describes an implantable prosthetic device for hip replacement surgery, not a device used to diagnose medical conditions.
No
The device description clearly states it is a physical hip stem manufactured from titanium alloy with a hydroxyapatite coating, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the conditions for which a total or partial hip replacement is indicated. These are all related to treating musculoskeletal issues and injuries within the human body.
- Device Description: The device is a hip stem, a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo (within the body) implant used for surgical treatment.
N/A
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 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
Product codes
LZO, MEH, KWL, KWY
Device Description
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.
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, acetabulum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 O
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042992, K093736, K190344, K192946, K203167
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2023 |
See PRA Statement below.
3
510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedic Drive |
| Warsaw, IN 46852 | |
| Phone number | (574) 404-8348 |
| Fax number | N/A |
| Establishment | |
| Registration Number | 1818910 |
| Name of contact person | Paul Shin |
| Date prepared | December 7, 2021 |
| 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 888.3353, 888.3360, 888.3390 |
| Product Code(s) | LZO, MEH, KWL, KWY |
| Legally marketed | |
| device(s) to which | |
| equivalence 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 Hip | |
| stems 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 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. | |
| 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. 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. |
4
5
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE
COMPARED
| TO THE PREDICATE DEVICE | ||||
|---|---|---|---|---|
| Characteristics | Subject Device | |||
| DePuy Corail | ||||
| AMT | ||||
| Hip Prosthesis | ||||
| DePuy Corail | ||||
| Revision | ||||
| Hip Prosthesis | Primary | |||
| Predicate | ||||
| DePuy Corail | ||||
| AMT | ||||
| Hip Prosthesis | ||||
| (K042992) | Additional | |||
| Predicates | ||||
| DePuy Corail | ||||
| AMT Hip | ||||
| Prosthesis | ||||
| (K203167, | ||||
| K190344) | Additional | |||
| Predicates | ||||
| DePuy Corail | ||||
| Revision | ||||
| Hip Prosthesis | ||||
| (K203167, | ||||
| K192946, | ||||
| K093736) | ||||
| 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 |
| Sterilization | ||||
| Method | Gamma | Same | Same | Same |
| Packaging | Nylon Inner Pouch | |||
| and outer PETG | ||||
| blister with Tyvek | ||||
| peel lid | Same | Same | Same | |
| Shelf life | 10 Years | 5 Years | 10 Years | 10 Years |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | ||||
| SUBSTANTIAL EQUIVALENCE |
6
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).