NexGen® Legacy®

FDA UDI

Class III (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: NexGen® Legacy® FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Model / Reference: 5960-15-52 FDA UDI

Identifiers

Catalog Number: 00-5960-015-52 FDA UDI
Primary DI / UDI-DI: 00889024001022 FDA UDI
PMA Number: P060037 FDA UDI
510(k) Number: K173057 FDA UDI
K991581 FDA UDI
FDA Product Code: NJL FDA UDI
JWH 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

K991581 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 III	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI 03e2dc90-3c85-4f70-a878-e7f2957eebce 36 fields · synced May 30, 2026