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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K251680

510(k) cleared

Biosteon® Screw

Biocomposites, Ltd. · Feb 17, 2026 · K251680

FDA cleared the Biosteon® Screw from Biocomposites, Ltd. on Feb 17, 2026 under K251680, a traditional 510(k). The device falls under product code MAI, Fastener, Fixation, Biodegradable, Soft Tissue, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 30, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Biocomposites, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251680?

K251680 is the FDA 510(k) for Biosteon® Screw, submitted by Biocomposites, Ltd.. FDA's decision date was Feb 17, 2026, under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue).

Who makes the Biosteon® Screw?

Biocomposites, Ltd., based in Keele, is the applicant of record for K251680.

How long did the K251680 review take?

FDA received the submission on May 30, 2025 and issued its decision on Feb 17, 2026, 263 days later.

← All decisions in February 2026