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FDA 510(k)

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

K-Number: K242865 · 2025-06-12

ApplicantBiocomposites, Ltd.
Decision Date2025-06-12
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K242865. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K242865.

When did Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer receive FDA 510(k) clearance?

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer received FDA 510(k) clearance on 2025-06-12, under 510(k) number K242865.

Who is the listed applicant for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

The FDA 510(k) record lists Biocomposites, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer?

The FDA product code for Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer is KWL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Biocomposites, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251680Biosteon® ScrewK250521NanoBone® SBX Putty ; NanoBone® QDK212721Genex Bone Graft Substitute

Related Devices (Code: KWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbHK222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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