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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 / March 2026 / K260112

510(k) cleared

QuikFix External Fixator: Knee-Spanning Pack

Stabiliz Orthopaedics, Inc. · Mar 23, 2026 · K260112

FDA cleared the QuikFix External Fixator: Knee-Spanning Pack from Stabiliz Orthopaedics, Inc. on Mar 23, 2026 under K260112, a traditional 510(k). The device falls under product code KTT, Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 14, 2026. The decision came 68 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Stabiliz Orthopaedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260112?

K260112 is the FDA 510(k) for QuikFix External Fixator: Knee-Spanning Pack, submitted by Stabiliz Orthopaedics, Inc.. FDA's decision date was Mar 23, 2026, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the QuikFix External Fixator: Knee-Spanning Pack?

Stabiliz Orthopaedics, Inc., based in Exton, PA, is the applicant of record for K260112.

How long did the K260112 review take?

FDA received the submission on Jan 14, 2026 and issued its decision on Mar 23, 2026, 68 days later.

← All decisions in March 2026