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Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

510(k) K172634

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

This device is named in the recall

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 NumberK172634 Date16 Nov 2017ClearedStatusActive

Recalls

7 recalls · 7 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1262-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1263-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1261-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1265-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1264-2024 FDA Class II initiated 6 Feb 2024
    • Ongoing Z-1266-2024 FDA Class II initiated 6 Feb 2024

    Potential packaging breaches of inner blister and outer sterile blister.

    • Ongoing Z-1654-2023 FDA Class II initiated 13 Apr 2023

    Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

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  • Withdrawn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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