OSS™ Orthopedic Salvage System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: OSS™ Orthopedic Salvage System FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Model / Reference: 151805 FDA UDI

Identifiers

Catalog Number: 151805 FDA UDI
Primary DI / UDI-DI: 00880304674271 FDA UDI
510(k) Number: K002757 FDA UDI
K021260 FDA UDI
K051479 FDA UDI
K051570 FDA UDI
K060131 FDA UDI
K080330 FDA UDI
K123501 FDA UDI
K140509 FDA UDI
K141331 FDA UDI
FDA Product Code: KRO FDA UDI
JDI FDA UDI
LPH FDA UDI
KWY FDA UDI
LZO FDA UDI
KWT FDA UDI
KWZ FDA UDI
MEH FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
888.3350 FDA UDI
888.3358 FDA UDI
888.3390 FDA UDI
888.3353 FDA UDI
888.3650 FDA UDI
888.3310 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

Yes

FDA UDI

Category: Uncoated knee femur prosthesis, metallic

OSS™ Orthopedic Salvage System by Biomet Orthopedics, Inc. — Class II — 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
Natural-Knee® — Zimmer, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · 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

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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 6147733e-24f8-4b08-84c2-35146f592304 36 fields · synced Jun 8, 2026