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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 K263583
Device Name Tornier Humeral Reconstruction System (HRS) Tuberosity Body
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55441
Applicant Contact Rachel Zigler
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55441
Correspondent Contact Rachel Zigler
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   PHX  
Date Received09/30/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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