ArthroTAK said on September 4 that FDA cleared expanded indications for its sutureless tendon anchor, adding lateral extra-articular tenodesis in the knee. The Orlando, Florida company's first 510(k), K252635, covered soft tissue to bone fixation in open and arthroscopic biceps tenodesis. That clearance came on May 1, 2026, 254 days after FDA received the traditional submission on August 20, 2025.
The device is a PEEK implant driven through tendon into bone with a mallet and locked by turning the inserter knob. It uses no sutures, suture passers, knots or power tools. ArthroTAK says deployment takes 45 to 60 seconds and that surgeons have completed more than 80 biceps tenodesis cases with it.
The sequence is the useful part. ArthroTAK cleared the narrow biceps indication first, then returned with a second 510(k) for the knee four months later. The company says versions for the shoulder, the foot and ankle, and the wrist are in development. The new K number had not posted to FDA's 510(k) database as of September 6. Dr. Amit Nathani is the founder and designing surgeon, and Justin Kaler is general manager.