Identity
- Trade Name
- NexGen® Legacy® FDA UDI
- Generic Name
- Uncoated knee femur prosthesis, metallic FDA UDI
- Model / Reference
- 5996-17-52 FDA UDI
Identifiers
- Catalog Number
- 00-5996-017-52 FDA UDI
- Primary DI / UDI-DI
- 00889024001541 FDA UDI
- PMA Number
- P060037 FDA UDI
- FDA Product Code
- NJL FDA UDIJWH FDA UDI
- GMDN Term
- Uncoated knee femur prosthesis, metallic FDA UDI
Classification
- Device Class
- Class III 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
MR Conditional FDA UDI
Category: Uncoated knee femur prosthesis, metallic
NexGen® Legacy® by Zimmer, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee femur prosthesis, metallic.
- SIGMA — DEPUY (IRELAND) · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
- GMK Sphere Revision System — Medacta International · Class II
- ACS® — implantcast GmbH · Class II
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K173057 also covers:
- 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.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
- Natural-Knee® — Zimmer, Inc.
K960279 also covers:
- NexGen Knee System — Zimmer, Inc.
- NexGen Knee System — Zimmer, Inc.
- NexGen Knee System — Zimmer, Inc.
- NexGen Knee System — Zimmer, Inc.
- NexGen Knee System — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
P060037 also covers:
- NexGen® — Zimmer, Inc.
- NexGen® — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Complete Knee Solution — Zimmer, Inc.
- NexGen® Legacy® — 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 299b17d4-4c91-4aa9-9ca6-cd8cc5e8e6be 36 fields · synced May 30, 2026