Dunamis Screw and Suture Locking System

The Dunamis Screw and Suture Locking System is an orthopedic fixation device consisting of standalone bone screws and suture locking components for bone-to-bone and soft tissue-to-bone fixation. It is used in procedures including ACL/PCL repair, ligament reconstruction, and fracture repair in adult and pediatric patients, provided the device does not interfere with growth plates.

The device features screws with integrated suture locking capabilities (button cap or locking pin designs) that lock sutures knotlessly, compatible with previously cleared Dunamis Force DFX sutures and suture tapes. Components are manufactured from stainless steel and titanium alloy in various diameters, lengths, and configurations (headed, headless, threaded, non-threaded). A suture wheel component can be used standalone or with compatible orthopedic plates with threaded or non-threaded post adapters.

ASTM F543 screw testing was performed, along with static and dynamic construct testing and engineering worst-case rationales.

The device shares the same indications, materials, sterilization methods, and fundamental technology as its predicates. While the suture-locking mechanism (button cap or locking pin) differs from the knot-based approach of Arthrex Blunt Tip Screws (K143702), it is based on the previously cleared Dunamis Button Fixation System (K191319) technology. The standalone screws are equivalent to the Paragon 28 Monster Screw System (K203011) in size, material, and application. Mechanical testing confirmed equivalent or superior static and dynamic strength performance across all configurations.