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Vanguard Xp Knee System

by Biomet Manufacturing Corp

510(k) K122160

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK122160 Date20 Mar 2013ClearedStatusActive

Recalls

12 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-2530-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2503-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2515-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2537-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2533-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2528-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2532-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2535-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2536-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2531-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2529-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160
    • Terminated Z-2534-2019 FDA Class II initiated 15 Aug 2019 on shared 510(k) K122160

    The locking bar not fully engaging

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  • Withdrawn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
MBH
Device Class
Class II
Regulation
21 CFR Part 888.3565
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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