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Triathlon Posteriorly Stabilized (Ps) Total Knee System

by Howmedica Osteonics Corp.

510(k) K031729

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 · Traditional NumberK031729 Date2 Sep 2003ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1095-2011 FDA Unclassified (pre-2012) initiated 22 Dec 2010

    Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).

    • Terminated Z-2334-2010 FDA Unclassified (pre-2012) initiated 1 Sep 2009

    A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.

    • Terminated Z-0910-2010 FDA Unclassified (pre-2012) initiated 17 Feb 2006

    Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

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  • Withdrawn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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