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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 / October 2026 / K263083

510(k) cleared

Response Ortho Smart Fixator - Hexapod System

Response Ortho Solutions, LLC · Oct 2, 2026 · K263083

FDA cleared the Response Ortho Smart Fixator - Hexapod System from Response Ortho Solutions, LLC on Oct 2, 2026 under K263083, a special 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 Sep 2, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Response Ortho Solutions, LLC has one other decision in the tracker over the last 12 months: K252625 (The Response Ortho Smart Fixator - Hexapod System).

Questions & Answers

What did FDA clear under K263083?

K263083 is the FDA 510(k) for Response Ortho Smart Fixator - Hexapod System, submitted by Response Ortho Solutions, LLC. FDA's decision date was Oct 2, 2026, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the Response Ortho Smart Fixator - Hexapod System?

Response Ortho Solutions, LLC, based in Boynton Beach, FL, is the applicant of record for K263083.

How long did the K263083 review take?

FDA received the submission on Sep 2, 2026 and issued its decision on Oct 2, 2026, 30 days later.

← All decisions in October 2026

Sources