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Triathlon Total Knee System

by Stryker Orthopaedics 2 variants

510(k) K053514

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK053514 Date26 Jan 2006ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0964-2013 FDA Class II initiated 24 Jan 2013 on shared 510(k) K053514

    The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.

    • Terminated Z-0889-2009 FDA Unclassified (pre-2012) initiated 13 Nov 2008

    Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

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  • Withdrawn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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