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Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

by Biomet Manufacturing Corp

510(k) K131135

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK131135 Date22 Jan 2014ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1661-2020 FDA Class II initiated 26 Feb 2020 on shared 510(k) K131135
    • Terminated Z-1658-2020 FDA Class II initiated 26 Feb 2020 on shared 510(k) K131135
    • Terminated Z-1659-2020 FDA Class II initiated 26 Feb 2020 on shared 510(k) K131135
    • Terminated Z-1660-2020 FDA Class II initiated 26 Feb 2020 on shared 510(k) K131135
    • Terminated Z-1657-2020 FDA Class II initiated 26 Feb 2020 on shared 510(k) K131135

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MBB
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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