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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 / April 2026 / K254158

510(k) cleared

SPINEART Navigation Instrument System

Spineart SA · Apr 9, 2026 · K254158

FDA cleared the SPINEART Navigation Instrument System from Spineart SA on Apr 9, 2026 under K254158, a special 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 22, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spineart SA has 4 other decisions in the tracker over the last 12 months: K262639 (BAGUERA® C Cervical Disc Surgical Instruments), P250042 (BAGUERA®C Cervical Disc Prosthesis), K261205 (SPINEART Navigation Instrument System), K253966 (PERLA® TL Posterior Thoraco-lumbar Fixation System).

Questions & Answers

What did FDA clear under K254158?

K254158 is the FDA 510(k) for SPINEART Navigation Instrument System, submitted by Spineart SA. FDA's decision date was Apr 9, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the SPINEART Navigation Instrument System?

Spineart SA, based in Plan-Les-Ouates, is the applicant of record for K254158.

How long did the K254158 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Apr 9, 2026, 108 days later.

← All decisions in April 2026

Sources