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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 / February 2026 / K253381

510(k) cleared

Stealth AXiS Surgical System with Stealth AXiS Spine clinical application

Medtronic Navigation, Inc. · Feb 12, 2026 · K253381

FDA cleared the Stealth AXiS Surgical System with Stealth AXiS Spine clinical application from Medtronic Navigation, Inc. on Feb 12, 2026 under K253381, a traditional 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 Sep 30, 2025. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Navigation, Inc. has 4 other decisions in the tracker over the last 12 months: K253379 (Stealth AXiS Cranial clinical application), K253395 (Stealth AXiS ENT clinical application), K253391 (Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)), K251282 (StealthStation S8 Spine Software).

Questions & Answers

What did FDA clear under K253381?

K253381 is the FDA 510(k) for Stealth AXiS Surgical System with Stealth AXiS Spine clinical application, submitted by Medtronic Navigation, Inc.. FDA's decision date was Feb 12, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Stealth AXiS Surgical System with Stealth AXiS Spine clinical application?

Medtronic Navigation, Inc., based in Lafayette, CO, is the applicant of record for K253381.

How long did the K253381 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Feb 12, 2026, 135 days later.

← All decisions in February 2026