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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 / K252625

510(k) cleared

The Response Ortho Smart Fixator - Hexapod System

Response Ortho Solutions, LLC · Nov 20, 2025 · K252625

FDA cleared the The Response Ortho Smart Fixator - Hexapod System from Response Ortho Solutions, LLC on Nov 20, 2025 under K252625, 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 19, 2025. The decision came 93 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 Response Ortho Solutions, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252625?

K252625 is the FDA 510(k) for The Response Ortho Smart Fixator - Hexapod System, submitted by Response Ortho Solutions, LLC. FDA's decision date was Nov 20, 2025, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the The Response Ortho Smart Fixator - Hexapod System?

Response Ortho Solutions, LLC, based in Boca Raton, FL, is the applicant of record for K252625.

How long did the K252625 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Nov 20, 2025, 93 days later.

← All decisions in November 2025