Omnifit (Tm) Total Knee Prosthesis System

by Osteonics Corp.

510(k) K863668

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K863668↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SN Traditional	NumberK863668	Date19 Dec 1986Decided	StatusActive

Recalls

4 recalls · 4 ongoing · FDA

4 recalls, same reason
- Ongoing Z-0872-2024 FDA Class II initiated 1 Dec 2023
- Ongoing Z-0869-2024 FDA Class II initiated 1 Dec 2023
- Ongoing Z-0870-2024 FDA Class II initiated 1 Dec 2023
- Ongoing Z-0871-2024 FDA Class II initiated 1 Dec 2023
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K863668
FDA Product Code: JWH

Device Class: Class II
Regulation: 21 CFR Part 888.3560
Advisory Committee: Orthopedic
FDA Decision: SN

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