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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 / K254107

510(k) cleared

Refobacin Bone Cement R (110034355)

Biomet France · Apr 15, 2026 · K254107

FDA cleared the Refobacin Bone Cement R (110034355) from Biomet France on Apr 15, 2026 under K254107, a traditional 510(k). The device falls under product code LOD, Bone Cement, regulated at 21 CFR 888.3027 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 19, 2025. The decision came 117 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 Biomet France in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254107?

K254107 is the FDA 510(k) for Refobacin Bone Cement R (110034355), submitted by Biomet France. FDA's decision date was Apr 15, 2026, under product code LOD (Bone Cement).

Who makes the Refobacin Bone Cement R (110034355)?

Biomet France, based in Valence, is the applicant of record for K254107.

How long did the K254107 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Apr 15, 2026, 117 days later.

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