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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 / March 2026 / K252961

510(k) cleared

Fusion FibFix Nail

Fusion Orthopedics USA, LLC · Mar 18, 2026 · K252961

FDA cleared the Fusion FibFix Nail from Fusion Orthopedics USA, LLC on Mar 18, 2026 under K252961, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 16, 2025. The decision came 183 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 Fusion Orthopedics USA, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252961?

K252961 is the FDA 510(k) for Fusion FibFix Nail, submitted by Fusion Orthopedics USA, LLC. FDA's decision date was Mar 18, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Fusion FibFix Nail?

Fusion Orthopedics USA, LLC, based in Mesa, AZ, is the applicant of record for K252961.

How long did the K252961 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Mar 18, 2026, 183 days later.

← All decisions in March 2026