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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 K262251
Device Name ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)
Applicant
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Applicant Contact Katherine Warren
Correspondent
Globus Medical, Inc.
Valley Forge Business Center
2560 General Armistead Ave.
Audubon,  PA  19403
Correspondent Contact Katherine Warren
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY  
Date Received07/01/2026
Decision Date 07/31/2026
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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