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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Connor Tighe
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Connor Tighe
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
HRY   HSX   KRR   MBH   NPJ  
Date Received09/19/2024
Decision Date 12/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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