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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 / 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: 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 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