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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 / January 2026 / K253990

510(k) cleared

KHEIRON® Spinal Fixation System, including patient specific K-ROD

S.M.A.I.O · Jan 7, 2026 · K253990

FDA cleared the KHEIRON® Spinal Fixation System, including patient specific K-ROD from S.M.A.I.O on Jan 7, 2026 under K253990, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 12, 2025. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

S.M.A.I.O has 8 other decisions in the tracker over the last 12 months: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

Questions & Answers

What did FDA clear under K253990?

K253990 is the FDA 510(k) for KHEIRON® Spinal Fixation System, including patient specific K-ROD, submitted by S.M.A.I.O. FDA's decision date was Jan 7, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the KHEIRON® Spinal Fixation System, including patient specific K-ROD?

S.M.A.I.O, based in Saint-Priest, is the applicant of record for K253990.

How long did the K253990 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Jan 7, 2026, 26 days later.

← All decisions in January 2026