FDA 510(k)

Biosteon® Screw

K-Number: K251680 · 2026-02-17

Decision Date2026-02-17

Product CodeMAI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Biosteon® Screw is a medical device manufactured by Biocomposites, Ltd.. It received FDA 510(k) clearance on 2026-02-17 under approval number K251680. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biosteon® Screw?

Biosteon® Screw is a medical device that received FDA 510(k) clearance on 2026-02-17. It is manufactured by Biocomposites, Ltd.. The 510(k) number is K251680.

When was Biosteon® Screw approved by the FDA?

Biosteon® Screw received FDA 510(k) clearance on 2026-02-17, under approval number K251680.

What company makes Biosteon® Screw?

Biosteon® Screw is manufactured by Biocomposites, Ltd..

What is the FDA product code for Biosteon® Screw?

The FDA product code for Biosteon® Screw is MAI.

Other Devices by Biocomposites, Ltd.

K212721Genex Bone Graft Substitute K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer K250521NanoBone® SBX Putty ; NanoBone® QD

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Official Source

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