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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 / May 2026 / K253883

510(k) cleared

Bonalive Maxillofacial

Bonalive , Ltd. · May 14, 2026 · K253883

FDA cleared the Bonalive Maxillofacial from Bonalive , Ltd. on May 14, 2026 under K253883, a special 510(k). The device falls under product code LYC, Bone Grafting Material, Synthetic, regulated at 21 CFR 872.3930 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 4, 2025. The decision came 161 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 Bonalive , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253883?

K253883 is the FDA 510(k) for Bonalive Maxillofacial, submitted by Bonalive , Ltd.. FDA's decision date was May 14, 2026, under product code LYC (Bone Grafting Material, Synthetic).

Who makes the Bonalive Maxillofacial?

Bonalive , Ltd., based in Turku, is the applicant of record for K253883.

How long did the K253883 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on May 14, 2026, 161 days later.

← All decisions in May 2026