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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 / K253524

510(k) cleared

Adaptos®Fuse Bone Graft

Biomendex OY · Feb 17, 2026 · K253524

FDA cleared the Adaptos®Fuse Bone Graft from Biomendex OY on Feb 17, 2026 under K253524, a traditional 510(k). The device falls under product code MQV, Filler, Bone Void, Calcium Compound, regulated at 21 CFR 888.3045 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 13, 2025. The decision came 96 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 Biomendex OY in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253524?

K253524 is the FDA 510(k) for Adaptos®Fuse Bone Graft, submitted by Biomendex OY. FDA's decision date was Feb 17, 2026, under product code MQV (Filler, Bone Void, Calcium Compound).

Who makes the Adaptos®Fuse Bone Graft?

Biomendex OY, based in Tampere, is the applicant of record for K253524.

How long did the K253524 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Feb 17, 2026, 96 days later.

← All decisions in February 2026