Skip to content

Stageone Select Cement Spacer Molds for Temporary Hip Replacement

by Biomet Manufacturing Corp

510(k) K080979

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK080979 Date31 Oct 2008ClearedStatusActive

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-1641-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1649-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1640-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1648-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1651-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1638-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1650-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1643-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1646-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1642-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1645-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1644-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1652-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1639-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1647-2020 FDA Class II initiated 26 Feb 2020

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

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  • Withdrawn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
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Biomet Manufacturing Corp

See all devices from Biomet Manufacturing Corp →