WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K251750

510(k) cleared

Trax EX Anchor

Trax Surgical, Inc. · Mar 12, 2026 · K251750

FDA cleared the Trax EX Anchor from Trax Surgical, Inc. on Mar 12, 2026 under K251750, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 9, 2025. The decision came 276 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K251750?

K251750 is the FDA 510(k) for Trax EX Anchor, submitted by Trax Surgical, Inc.. FDA's decision date was Mar 12, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Trax EX Anchor?

Trax Surgical, Inc., based in Stoughton, MA, is the applicant of record for K251750.

How long did the K251750 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Mar 12, 2026, 276 days later.

← All decisions in March 2026