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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K260721
Device Name Tornier Perform Advanced Glenoid
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Stefanie Tarara
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Stefanie Tarara
Regulation Number888.3660
Classification Product Code
KWS  
Date Received03/05/2026
Decision Date 07/22/2026
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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