Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer— 510(k) K242865

Substantially Equivalent

Biocomposites, Ltd.

FDA 510(k) clearance K242865 for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer, Substantially Equivalent on 2025-06-12. Applicant: Biocomposites, Ltd..

Clearance details

Applicant: Biocomposites, Ltd.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2024-09-20
Decision date: 2025-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keele, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.