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Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford Partial Knee Replacement System

by Biomet Manufacturing Corp

510(k) K122277

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

30 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 NumberK122277 Date22 Oct 2012ClearedStatusActive

Recalls

30 recalls · FDA

  • 30 recalls, same reason

    • Terminated Z-1706-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1712-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1713-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1709-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1724-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1720-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1708-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1717-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1715-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1711-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1704-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1716-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1701-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1703-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1697-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1702-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1718-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1696-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1698-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1723-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1722-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1707-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1710-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1700-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1719-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1695-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1705-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1714-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1699-2013 FDA Class II initiated 7 Jun 2013
    • Terminated Z-1721-2013 FDA Class II initiated 7 Jun 2013

    Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

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
HRY
Device Class
Class II
Regulation
21 CFR Part 888.3530
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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