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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K262057
Device Name GMK Extension
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Dr.
Suite 101
Memphis,  TN  38141
Correspondent Contact Christopher Lussier
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/18/2026
Decision Date 09/15/2026
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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