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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K251680
Device Name Biosteon® Screw
Applicant
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Applicant Contact Ciara Airey
Correspondent
Bruder Consulting & Venture Group
38 True Harbour Way
West Islip,  NY  11795
Correspondent Contact Scott Bruder
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received05/30/2025
Decision Date 02/17/2026
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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