NexGen®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: NexGen® FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Model / Reference: 5881-14-02 FDA UDI

Identifiers

Catalog Number: 00-5881-014-02 FDA UDI
Primary DI / UDI-DI: 00889024199798 FDA UDI
510(k) Number: K152494 FDA UDI
FDA Product Code: JWH FDA UDI
KRO FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3510 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee femur prosthesis trial, reusable

NexGen® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Lospa Modular Knee System — Corentec Co., Ltd · Class II
OSS™ — Biomet Orthopedics, Inc. · Class II
VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class II
OSS™ — Biomet Orthopedics, Inc. · Class I
APEX Knee System — OMNIlife science, Inc. · Class I

Cleared under the same submission

K152494 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: Zimmer, Inc.

Sources (1)

FDA UDI 3f0b9878-2b16-4456-a50f-ca37f4211d67 36 fields · synced May 30, 2026