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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 K243293
Device Name Zimmer® Persona® Personalized Knee System
Applicant
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Adam Haas
Correspondent
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Adam Haas
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received10/18/2024
Decision Date 12/20/2024
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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