K242831

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

510(k) number
K242831
Device name
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
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics NJ · US
Product code
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrai
Decision date
2024-12-04
Date received
2024-09-19
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain

Also available from FDA: K242831.pdf

Official FDA record: K242831
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.