Identity
- Trade Name
- Gender Solutions® Natural-Knee® FDA UDI
- Generic Name
- Metal-backed patella prosthesis FDA UDI
- Model / Reference
- 00-5418-000-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024189423 FDA UDI
- 510(k) Number
- K073286 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Metal-backed 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: Metal-backed patella prosthesis
Gender Solutions® Natural-Knee® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-backed patella prosthesis.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- LCS COMPLETE — DEPUY (IRELAND) · Class III
- LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
- Triathlon — Howmedica Osteonics Corp. · Class II
- Triathlon — Howmedica Osteonics Corp. · Class II
- LCS COMPLETE — DEPUY ORTHOPAEDICS, INC. · Class III
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K073286 also covers:
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
- Gender Solutions® Natural-Knee® Prolong® — Zimmer, Inc.
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
- Zimmer, Inc.
Sources (1)
- FDA UDI cd13f770-2fc0-4f4a-afc3-adec9287f65f 35 fields · synced Jun 6, 2026