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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K253674
Device Name Blueprint Patient-Specific Instrumentation
Applicant
Stryker Corporation (Tornier, S.A.S.)
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Applicant Contact Aymen Azaiez
Correspondent
Stryker Corporation (Tornier, S.A.S.)
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Correspondent Contact Aymen Azaiez
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
QHE  
Date Received11/21/2025
Decision Date 04/03/2026
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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