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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K261275
Device Name Unity Total Knee System, Unity Knee Cementless CR Femur
Applicant
Corin, Ltd.
The Corinium Centre
Cirencester,  GB GL7 1YJ
Applicant Contact Marine De Paoli
Correspondent
Corin, Ltd.
The Corinium Centre
Cirencester,  GB GL7 1YJ
Correspondent Contact Marine De Paoli
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received04/17/2026
Decision Date 09/17/2026
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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