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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 / April 2026 / K260228

510(k) cleared

POYA 3.5mm Medial Proximal Tibia System

Bonebridge AG · Apr 24, 2026 · K260228

FDA cleared the POYA 3.5mm Medial Proximal Tibia System from Bonebridge AG on Apr 24, 2026 under K260228, 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 Jan 26, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Bonebridge AG has 2 other decisions in the tracker over the last 12 months: K261351 (SALGINA 2.5mm Distal Radius System), K252191 (BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System).

Questions & Answers

What did FDA clear under K260228?

K260228 is the FDA 510(k) for POYA 3.5mm Medial Proximal Tibia System, submitted by Bonebridge AG. FDA's decision date was Apr 24, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the POYA 3.5mm Medial Proximal Tibia System?

Bonebridge AG, based in Zug, is the applicant of record for K260228.

How long did the K260228 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Apr 24, 2026, 88 days later.

← All decisions in April 2026

Sources