ArthroTAK, LLC - FDA 510(k) Cleared Devices

ArthroTAK, LLC develops sutureless tendon-to-bone fixation technology for orthopedic surgery. The company specializes in simplifying biceps tenodesis and related procedures through innovative fixation devices. ArthroTAK operates with a manufacturing facility in Missoula, US.

The company has received 1 FDA 510(k) clearance from 1 total submission. ArthroTAK's focus is Orthopedic devices, representing 100% of its regulatory submissions. The company achieved its first and latest clearance in 2026, demonstrating active regulatory engagement.

ArthroTAK's cleared device addresses core surgical challenges by eliminating sutures and reducing operative time. The technology emphasizes consistent, reliable fixation with demonstrated strength advantages over traditional methods. The company positions its solution as cost-effective and surgeon-friendly for hospital and ambulatory surgical center settings.

Explore the company's device names, product codes, and clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by RPC Consulting, LLC as regulatory consultant.