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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 / May 2026 / K260989

510(k) cleared

Varion Thoracolumbar Fixation System

Kyocera Medical Technologies Inc. (KMTI) · May 15, 2026 · K260989

FDA cleared the Varion Thoracolumbar Fixation System from Kyocera Medical Technologies Inc. (KMTI) on May 15, 2026 under K260989, 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 Mar 25, 2026. The decision came 51 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Kyocera Medical Technologies Inc. (KMTI) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260989?

K260989 is the FDA 510(k) for Varion Thoracolumbar Fixation System, submitted by Kyocera Medical Technologies Inc. (KMTI). FDA's decision date was May 15, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Varion Thoracolumbar Fixation System?

Kyocera Medical Technologies Inc. (KMTI), based in Redlands, CA, is the applicant of record for K260989.

How long did the K260989 review take?

FDA received the submission on Mar 25, 2026 and issued its decision on May 15, 2026, 51 days later.

← All decisions in May 2026