FDA cleared the ArthroTAK Tendon Anchor Kit from ArthroTAK, LLC on Sep 2, 2026 under K262809, a special 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 7, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).
ArthroTAK, LLC has one other decision in the tracker over the last 12 months: K252635 (ArthroTAK Tendon Anchor Kit).
Questions & Answers
What did FDA clear under K262809?
K262809 is the FDA 510(k) for ArthroTAK Tendon Anchor Kit, submitted by ArthroTAK, LLC. FDA's decision date was Sep 2, 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 K262809. The company is listed in the MedDevice Startups directory.
How long did the K262809 review take?
FDA received the submission on Aug 7, 2026 and issued its decision on Sep 2, 2026, 26 days later.