Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

The Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is an interference screw composed of medical-grade titanium alloy (Ti6-AL4-V ELI) supplied sterile for single use. It is indicated for fixation of grafts in ligament reconstruction procedures including ACL/PCL, MCL, LCL, PLC, and MPFL reconstructions, with both standard and reverse thread designs available.

The device is manufactured from Titanium Ti6-AL4-V ELI alloy per ASTM F-136, features a 3.5 mm hex driver interface, is cannulated for use with guide wire accessories, has a variable or graduated lead-in thread to ease insertion, and has a flat beveled edge head profile with a thread starter marker. These characteristics are unchanged from the predicate device K231819.

ASTM F-136 (titanium alloy specification). Bench testing for fixation strength of synthetic grafts is referenced, demonstrating sufficient fixation strength to meet minimum clinical requirements for the intended reinforcement function.

The subject device is physically identical to the legally marketed predicate (K231819) in form and technological characteristics, so prior bench testing from K231819 and K212547 remains applicable. Additional bench testing demonstrates that synthetic graft fixation with these screws achieves sufficient strength for the intended reinforcement function without introducing new safety or performance questions. The indications are substantively unchanged—only specific graft types were removed from the statement as not applicable to indication language, but actual clinical use remains the same.