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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K261898
Device Name Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
Applicant
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Elizabeth Jodon
Correspondent
Howmedica Osteonics Corp. dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Elizabeth Jodon
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JWH   MBH  
Date Received06/05/2026
Decision Date 08/06/2026
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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