Skip to content

Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial

by Biomet Manufacturing, LLC

510(k) K142814

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142814 Date25 Jun 2015ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2232-2019 FDA Class II initiated 2 Jul 2019
    • Terminated Z-2234-2019 FDA Class II initiated 2 Jul 2019
    • Terminated Z-2235-2019 FDA Class II initiated 2 Jul 2019
    • Terminated Z-2233-2019 FDA Class II initiated 2 Jul 2019
    • Terminated Z-2231-2019 FDA Class II initiated 2 Jul 2019
    • Terminated Z-2236-2019 FDA Class II initiated 2 Jul 2019

    Cleaning processes potentially being ineffective

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Biomet Manufacturing Corp

See all devices from Biomet Manufacturing Corp →