Skip to content

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)

510(k) K190991

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 NumberK190991 Date15 Aug 2019ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2757-2019 FDA Class II initiated 19 Aug 2019
    • Terminated Z-2760-2019 FDA Class II initiated 19 Aug 2019
    • Terminated Z-2759-2019 FDA Class II initiated 19 Aug 2019
    • Terminated Z-2758-2019 FDA Class II initiated 19 Aug 2019

    Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

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  • Withdrawn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

Other devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics

See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →