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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K260934
Device Name TITAN Nail; APTUS K-Wire System
Applicant
Medartis AG
Hochbergerstrasse 60e
Basel,  CH 4057
Applicant Contact Salvatore Risoli
Correspondent
Medartis AG
Hochbergerstrasse 60e
Basel,  CH 4057
Correspondent Contact Salvatore Risoli
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received03/20/2026
Decision Date 04/17/2026
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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