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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 / May 2026 / K261145

510(k) cleared

Avanti Distal Elbow ORIF System

Avanti Orthopaedics, LLC · May 9, 2026 · K261145

FDA cleared the Avanti Distal Elbow ORIF System from Avanti Orthopaedics, LLC on May 9, 2026 under K261145, a abbreviated 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 Apr 7, 2026. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Avanti Orthopaedics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261145?

K261145 is the FDA 510(k) for Avanti Distal Elbow ORIF System, submitted by Avanti Orthopaedics, LLC. FDA's decision date was May 9, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Avanti Distal Elbow ORIF System?

Avanti Orthopaedics, LLC, based in Wilmington, DE, is the applicant of record for K261145.

How long did the K261145 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on May 9, 2026, 32 days later.

← All decisions in May 2026