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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K242865
Device Name Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
Applicant
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Applicant Contact Melisa Lamanna
Correspondent
Biocomposites, Ltd.
Keele Science Park
Keele,  GB ST5 5NL
Correspondent Contact Melisa Lamanna
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Codes
HSD   JWH   KWS   KWY  
Date Received09/20/2024
Decision Date 06/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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