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Topez Total Ankle Replacement

by Topez Orthopedics, Inc.

510(k) K051023

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK051023 Date15 Nov 2005ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0139-2023 FDA Class II initiated 30 Sep 2022
    • Terminated Z-0140-2023 FDA Class II initiated 30 Sep 2022

    The tibial tray lock detail is oversized (larger than specification).

    • Terminated Z-1924-2020 FDA Class II initiated 9 Apr 2020

    One lot of INBONE Tibial Trays is missing the plasma coating.

    • Terminated Z-0565-2020 FDA Class II initiated 8 Nov 2016

    The firm discovered a lack of adequate documentation confirming sterility on certain products.

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  • Withdrawn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
HSN
Device Class
Class II
Regulation
21 CFR Part 888.3110
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent