Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

• • Terminated Z-1379-2021 FDA Class II ·initiated 5 Mar 2021

  The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

510(k) Number

K172326 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Simplex P Bone Cement

  Class II

  FDA 510(k) K062553 Active Cleared 8 Jan 2007

• Short Citation Femoral Stem

  Class II

  FDA 510(k) K053528 Active Cleared 13 Jan 2006

• Insignia Hip Stem

  Class II

  FDA 510(k) K211703 Active Cleared 16 Aug 2021

• EXETER Centralizer, EXETER 2.5mm Plug

  Class II

  FDA 510(k) K191414 Active Cleared 28 Aug 2019

• Trident T Acetabular Shells

  Class II

  FDA 510(k) K040412 Active Cleared 25 May 2004

• Triathlon Knee System Posterior Stabilized Components Open recall

  Class II

  FDA 510(k) K141056 Active Cleared 5 Aug 2014

See all devices from Stryker Orthopaedics →