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 / May 2026 / K252635

510(k) cleared

ArthroTAK Tendon Anchor Kit

ArthroTAK, LLC · May 1, 2026 · K252635

FDA cleared the ArthroTAK Tendon Anchor Kit from ArthroTAK, LLC on May 1, 2026 under K252635, 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 Aug 20, 2025. The decision came 254 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 ArthroTAK, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252635?

K252635 is the FDA 510(k) for ArthroTAK Tendon Anchor Kit, submitted by ArthroTAK, LLC. FDA's decision date was May 1, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the ArthroTAK Tendon Anchor Kit?

ArthroTAK, LLC, based in Missoula, MT, is the applicant of record for K252635.

How long did the K252635 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on May 1, 2026, 254 days later.

← All decisions in May 2026