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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 / K261607

510(k) cleared

Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System

Spinal Simplicity, LLC · Oct 2, 2026 · K261607

FDA cleared the Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System from Spinal Simplicity, LLC on Oct 2, 2026 under K261607, a traditional 510(k). The device falls under product code PEK, Spinous Process Plate, regulated at 21 CFR 888.3050 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 14, 2026. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spinal Simplicity, LLC has 2 other decisions in the tracker over the last 12 months: K253523 (Freedom DS Decompression System), K253250 (Minuteman® G6 MIS Fusion Plate).

Questions & Answers

What did FDA clear under K261607?

K261607 is the FDA 510(k) for Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System, submitted by Spinal Simplicity, LLC. FDA's decision date was Oct 2, 2026, under product code PEK (Spinous Process Plate).

Who makes the Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System?

Spinal Simplicity, LLC, based in Overland Park, KS, is the applicant of record for K261607.

How long did the K261607 review take?

FDA received the submission on May 14, 2026 and issued its decision on Oct 2, 2026, 141 days later.

← All decisions in October 2026

Sources