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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K254093
Device Name DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
Applicant
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Applicant Contact Gengqiao Peng
Correspondent
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Gengqiao Peng
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/19/2025
Decision Date 03/10/2026
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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