510(k) K242865

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer by Biocomposites, Ltd. — Product Code KWL

K242865 is an FDA 510(k) premarket notification submitted by Biocomposites, Ltd. for the device "Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer". The FDA issued a decision of Substantially Equivalent on June 12, 2025. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Biocomposites, Ltd. has at least 10 other 510(k) clearances on record.