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Prelude Pf Femoral Components (Mim Cocrmo), Prelude Pf Femoral Components (Cast Cocrmo), Prelude Pf Patella Components,

by Biomet Manufacturing Corp

510(k) K123907

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK123907 Date3 Sep 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1318-2016 FDA Class II initiated 9 Mar 2016

    Inadequate design control.

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  • Withdrawn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
KRR
Device Class
Class II
Regulation
21 CFR Part 888.3540
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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