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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 / November 2025 / K252555

510(k) cleared

Medusa Orthopedics Boa External Fixation System

Medusa Orthopedics, LLC · Nov 25, 2025 · K252555

FDA cleared the Medusa Orthopedics Boa External Fixation System from Medusa Orthopedics, LLC on Nov 25, 2025 under K252555, a traditional 510(k). The device falls under product code KTT, Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 13, 2025. The decision came 104 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 Medusa Orthopedics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252555?

K252555 is the FDA 510(k) for Medusa Orthopedics Boa External Fixation System, submitted by Medusa Orthopedics, LLC. FDA's decision date was Nov 25, 2025, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the Medusa Orthopedics Boa External Fixation System?

Medusa Orthopedics, LLC, based in Fleetwood, PA, is the applicant of record for K252555.

How long did the K252555 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on Nov 25, 2025, 104 days later.

← All decisions in November 2025