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Advance 913 Medial Pivot Tibial Insert, Advance 913 Medial Pivot Tibial Base

by Wrightmedicaltechnologyinc

510(k) K092201

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Special NumberK092201 Date20 Aug 2009ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0183-2013 FDA Class II initiated 5 Sep 2012 on shared 510(k) K092201
    • Terminated Z-0185-2013 FDA Class II initiated 5 Sep 2012 on shared 510(k) K092201
    • Terminated Z-0184-2013 FDA Class II initiated 5 Sep 2012 on shared 510(k) K092201

    There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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