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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 / K260073

510(k) cleared

XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm

Biodynamik, Inc. · Feb 10, 2026 · K260073

FDA cleared the XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm from Biodynamik, Inc. on Feb 10, 2026 under K260073, a special 510(k). The device falls under product code JDW, Pin, Fixation, Threaded, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 9, 2026. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260073?

K260073 is the FDA 510(k) for XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm, submitted by Biodynamik, Inc.. FDA's decision date was Feb 10, 2026, under product code JDW (Pin, Fixation, Threaded).

Who makes the XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm?

Biodynamik, Inc., based in Lake Forest, CA, is the applicant of record for K260073.

How long did the K260073 review take?

FDA received the submission on Jan 9, 2026 and issued its decision on Feb 10, 2026, 32 days later.

← All decisions in February 2026