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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 / December 2025 / K253250

510(k) cleared

Minuteman® G6 MIS Fusion Plate

Spinal Simplicity, LLC · Dec 1, 2025 · K253250

FDA cleared the Minuteman® G6 MIS Fusion Plate from Spinal Simplicity, LLC on Dec 1, 2025 under K253250, 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 Sep 29, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Spinal Simplicity, LLC has 2 other decisions in the tracker over the last 12 months: K261607 (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), K253523 (Freedom DS Decompression System).

Questions & Answers

What did FDA clear under K253250?

K253250 is the FDA 510(k) for Minuteman® G6 MIS Fusion Plate, submitted by Spinal Simplicity, LLC. FDA's decision date was Dec 1, 2025, under product code PEK (Spinous Process Plate).

Who makes the Minuteman® G6 MIS Fusion Plate?

Spinal Simplicity, LLC, based in Overland Park, KS, is the applicant of record for K253250.

How long did the K253250 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 1, 2025, 63 days later.

← All decisions in December 2025