Cleared Traditional

K230952 - Triathlon? Total Knee System - Triathlon? Pro Posterior Stabilized (PS) Femoral Component
(FDA 510(k) Clearance)

Jun 2023
Decision
59d
Days
Class 2
Risk

K230952 is an FDA 510(k) clearance for the Triathlon? Total Knee System - Triathlon? Pro Posterior Stabilized (PS) Femoral Component, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on June 2, 2023, 59 days after receiving the submission on April 4, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K230952 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2023
Decision Date June 02, 2023
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

Similar Devices — JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 909
Materialise TKA Guide System
K253793 · Materialise NV · Jan 2026
EMPOWR Knee
K252974 · Encore Medical, L.P. · Dec 2025
ATTUNE? Total Knee System; ATTUNE? Revision Sleeve LPS? Femoral Adaptors
K253197 · Depuy Ireland UC · Nov 2025
Freedom Infinia? Total Knee System
K253314 · Maxx Orthopedics, Inc. · Oct 2025
Freedom? Total Knee System ? Titan PCK Components
K253144 · Maxx Orthopedics, Inc. · Oct 2025
Stem Extension Line (U2 Total Knee System?PSA Type)
K252725 · United Orthopedic Corporation · Sep 2025