Cleared Traditional

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System

K242831 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Dec 2024

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K242831 is an FDA 510(k) clearance for the Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System, 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 December 4, 2024, 76 days after receiving the submission on September 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K242831 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	December 04, 2024
Days to Decision	76 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