510(k) K230952

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

K230952 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

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