Cleared Traditional

Triathlon? Hinge Knee System

K223528 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Jan 2023
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K223528 is an FDA 510(k) clearance for the Triathlon? Hinge Knee System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on January 20, 2023, 58 days after receiving the submission on November 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K223528 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2022
Decision Date January 20, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

Similar Devices — KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 85
Triathlon? Tritanium? Asymmetric Patella; Triathlon? Tritanium? Symmetric Patella; Triathlon? Symmetric Patella; Triathlon? Asymmetric Patella; Scorpio? Universal Dome Patella; Triathlon? Hinge Bumper
K252898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2025
Stem Extension Line (USTAR II System)
K252303 · United Orthopedic Corporation · Aug 2025
Triathlon? Hinge Knee System
K251665 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2025
ATTUNE? Revision Hinge Knee
K242871 · Depuy Ireland UC · Nov 2024
EVOLUTION? Hinge Knee System;GUARDIAN? limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS? Limb Salvage System;EVOLUTION? MP Total Knee System; EVOLUTION? MP Total Knee System; EVOLUTION? MP Adaptive CS Insert; EVOLUTION? MP Adaptive PS Tibial Insert; EVOLUTION? MP CS/CR Porous Femur/EVOLUTION? Adaptive CS and PS Inserts; EVOLUTION? Revision CCK System; ADVANCE? Double High Insert; ADVANCE? A-CLASS? Tibial Insert; ADVANCE? Knee System; ADVANCE? Ultra-Congruent Tibial Inse
K240043 · Microport Orthopedics, Inc. · Apr 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K233980 · Depuy Ireland UC · Mar 2024

More from Howmedica Osteonics Corp.,...

View all
Triathlon? Total Knee System - Triathlon? X3? Medial Stabilized Tibial Bearing Insert
K253637 · MBH · Feb 2026
Triathlon? Tritanium? Asymmetric Patella; Triathlon? Tritanium? Symmetric Patella; Triathlon? Symmetric Patella; Triathlon? Asymmetric Patella; Scorpio? Universal Dome Patella; Triathlon? Hinge Bumper
K252898 · KRO · Dec 2025
Triathlon? Total Knee System - Triathlon? Gold Femoral Components
K252044 · MBH · Oct 2025
Stryker and Serf hip devices
K250989 · LPH · Jul 2025
Triathlon? Hinge Knee System
K251665 · KRO · Jul 2025