ArthroTAK Granted 510(k) for ArthroTAK Tendon Anchor Kit

ArthroTAK was granted FDA 510(k) clearance to market the ArthroTAK Tendon Anchor Kit, indicated for soft tissue to bone fixation in open and arthroscopic biceps tenodesis procedures.

The ArthroTAK Tendon Anchor Kit is a sterile, single-use, sutureless soft-tissue-to-bone fixation system. Its PEEK implant is delivered through the tendon and into bone in a single, mallet-driven step, then locked into place by simple clockwise rotation of the inserter knob. The system eliminates the need for sutures, suture passers, knot-tying, or power equipment, significantly reducing surgical complexity and procedural time.

Benchtop testing has demonstrated ultimate fixation strength competitive with leading marketed biceps tenodesis devices, well above the upper bound of normal physiological loads. The implant is compatible with all three standard surgical approaches: arthroscopic suprapectoral, arthroscopic high-groove, and open subpectoral. ArthroTAK can also be deployed percutaneously or through an 8 mm or larger cannula.

ArthroTAK’s product roadmap extends well beyond biceps tenodesis. The same modular fixation platform is being actively evaluated for additional sports medicine applications, to address an annual procedural volume of more than three million cases globally.

“Receiving FDA 510(k) clearance is a defining milestone for ArthroTAK and the culmination of years of work by our engineering team, surgeon advisors, and partners,” said Justin J. Kaler, General Manager of ArthroTAK. “Biceps tenodesis is a high-volume sports medicine procedure that has long been dominated by complex, suture-dependent techniques. ArthroTAK gives surgeons a faster, simpler, and more reproducible option, and gives Ambulatory Surgical Centers and hospitals a way to drive efficiency without compromising fixation strength.”

Source: ArthroTAK