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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 / September 2025 / K251791

510(k) cleared

Auxano® Wedge Fixation System

Auxano Medical, LLC · Sep 25, 2025 · K251791

FDA cleared the Auxano® Wedge Fixation System from Auxano Medical, LLC on Sep 25, 2025 under K251791, a traditional 510(k). The device falls under product code PLF, Bone Wedge, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 11, 2025. The decision came 106 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 Auxano Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251791?

K251791 is the FDA 510(k) for Auxano® Wedge Fixation System, submitted by Auxano Medical, LLC. FDA's decision date was Sep 25, 2025, under product code PLF (Bone Wedge).

Who makes the Auxano® Wedge Fixation System?

Auxano Medical, LLC, based in Brecksville, OH, is the applicant of record for K251791.

How long did the K251791 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Sep 25, 2025, 106 days later.

← All decisions in September 2025