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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Response Ortho Solutions, LLC has one other decision in the tracker over the last 12 months: K263083 (Response Ortho Smart Fixator - Hexapod System).

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

Sources