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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 / K252826

510(k) cleared

ARIX Femur Nail System

Jeil Medical Corporation · Dec 10, 2025 · K252826

FDA cleared the ARIX Femur Nail System from Jeil Medical Corporation on Dec 10, 2025 under K252826, 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 5, 2025. The decision came 96 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jeil Medical Corporation has one other decision in the tracker over the last 12 months: K252246 (Leforte MMF System).

Questions & Answers

What did FDA clear under K252826?

K252826 is the FDA 510(k) for ARIX Femur Nail System, submitted by Jeil Medical Corporation. FDA's decision date was Dec 10, 2025, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the ARIX Femur Nail System?

Jeil Medical Corporation, based in Seoul, is the applicant of record for K252826.

How long did the K252826 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on Dec 10, 2025, 96 days later.

← All decisions in December 2025

Sources