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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K253637
Device Name Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact Nora Armstrong
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact Nora Armstrong
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received11/19/2025
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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