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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 / July 2026 / K253802

510(k) cleared

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

S.M.A.I.O · Jul 1, 2026 · K253802

FDA cleared the KHEIRON® Spinal Fixation System, including patient specific K-ROD from S.M.A.I.O on Jul 1, 2026 under K253802, 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 Nov 28, 2025. The decision came 215 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K253802?

K253802 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 Jul 1, 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 K253802.

How long did the K253802 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jul 1, 2026, 215 days later.

← All decisions in July 2026