Oss™

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: OSS™ FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Model / Reference: 32-472036 FDA UDI

Identifiers

Catalog Number: 32-472036 FDA UDI
Primary DI / UDI-DI: 00887868486685 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee femur prosthesis trial, reusable

Biomet Orthopedics, LLC's OSS™ knee femur prosthesis trial device is a reusable, graduated size femoral articulation trials prosthesis designed for unicompartmental knee replacement surgery or total knee arthroplasty (TKA). This OSS™ device features femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. It is made of metal or polymer material and includes trial designs to determine the correct alignment, size, and fit of the final prosthesis. The OSS™ trial device is typically used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. With its unique set of graduated sizes, this device provides accurate sizing for optimal implantation. Biomet Orthopedics, LLC has labeled the OSS™ device as non-NRL due to the absence of MRI Safety Information. This device is exempt from PME regulations, allowing for safe use in clinical settings.

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Lospa Modular Knee System — Corentec Co., Ltd · Class II
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NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, Inc. · Class II
PERSONA® — Zimmer, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class II
NexGen® Legacy® — Zimmer, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 74a27995-68ed-47ef-8a34-d901c254b3dd 35 fields · synced Aug 2, 2026