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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 / December 2025 / K252191

510(k) cleared

BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System

Bonebridge AG · Dec 17, 2025 · K252191

FDA cleared the BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System from Bonebridge AG on Dec 17, 2025 under K252191, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 14, 2025. The decision came 156 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bonebridge AG has 2 other decisions in the tracker over the last 12 months: K261351 (SALGINA 2.5mm Distal Radius System), K260228 (POYA 3.5mm Medial Proximal Tibia System).

Questions & Answers

What did FDA clear under K252191?

K252191 is the FDA 510(k) for BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System, submitted by Bonebridge AG. FDA's decision date was Dec 17, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System?

Bonebridge AG, based in Zug, is the applicant of record for K252191.

How long did the K252191 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Dec 17, 2025, 156 days later.

← All decisions in December 2025

Sources