Cleared Traditional

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

K242865 · Biocomposites, Ltd. · Orthopedic

Jun 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K242865 is an FDA 510(k) clearance for the Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer, a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II — Special Controls, product code KWL), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on June 12, 2025, 265 days after receiving the submission on September 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number	K242865 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2024
Decision Date	June 12, 2025
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF