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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 K252898
Device Name Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Richa Sharma
Correspondent
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Richa Sharma
Regulation Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
JWH   MBH  
Date Received09/11/2025
Decision Date 12/15/2025
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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