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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K253721

510(k) cleared

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

S.M.A.I.O · Dec 17, 2025 · K253721

FDA cleared the KHEIRON® Spinal Fixation System, including patient specific K-ROD from S.M.A.I.O on Dec 17, 2025 under K253721, 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 24, 2025. The decision came 23 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: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K253721?

K253721 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 Dec 17, 2025, 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 K253721.

How long did the K253721 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 17, 2025, 23 days later.

← All decisions in December 2025