Identity
- Trade Name
- AMK FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 30mm FDA UDI
- Model / Reference
- 1484-92-025 FDA UDI
- Description
- AMK TOTAL KNEE SYSTEM ALL POLY PATELLA 3 PEG DOME 7.5mm x 30mm FDA UDI
Identifiers
- Catalog Number
- 148492025 FDA UDI
- Primary DI / UDI-DI
- 10603295039341 FDA UDI
- 510(k) Number
- K972643 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene patella prosthesis
Amk by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene patella prosthesis.
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- ADVANCE® — MicroPort Orthopedics Inc. · Class II
- Unity Total Knee System — CORIN LTD · Class II
- Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K972643 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 8d4b051a-b164-4f01-8f67-49d3d31e6b12 36 fields · synced Jun 6, 2026