510(k) K230952

Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2023
Date Received
April 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type