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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 K251840
Device Name Zimmer® Persona® Personalized Knee System
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Dora Hu
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Dora Hu
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OIY  
Date Received06/16/2025
Decision Date 05/28/2026
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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