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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 / K253545

510(k) cleared

Vulcan Spinal System

K2m, Inc. · Feb 10, 2026 · K253545

FDA cleared the Vulcan Spinal System from K2m, Inc. on Feb 10, 2026 under K253545, a traditional 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 14, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

K2m, Inc. has 2 other decisions in the tracker over the last 12 months: K260546 (Q Pedicle Instruments), K252873 (Q Interbody Instruments).

Questions & Answers

What did FDA clear under K253545?

K253545 is the FDA 510(k) for Vulcan Spinal System, submitted by K2m, Inc.. FDA's decision date was Feb 10, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Vulcan Spinal System?

K2m, Inc., based in Leesburg, VA, is the applicant of record for K253545.

How long did the K253545 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Feb 10, 2026, 88 days later.

← All decisions in February 2026

Sources