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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K262173
Device Name N22 Offset Humeral Head
Applicant
Shoulder Innovations, Inc.
1535 Steele Ave. SW
Suite B
Grand Rapids,  MI  49507
Applicant Contact Mark Hanes
Correspondent
Shoulder Innovations, Inc.
1535 Steele Ave. SW
Suite B
Grand Rapids,  MI  49507
Correspondent Contact Mark Hanes
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS  
Date Received06/26/2026
Decision Date 09/08/2026
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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