TITANEX Screw Systems

The TITANEX Screw Systems are cannulated bone screws made of titanium alloy with stainless steel instrumentation, available in headed, headless, partially, and fully threaded configurations in diameters from 2.0mm to 7.0mm. They are indicated for fracture fixation, osteotomies, reconstruction procedures, and arthrodesis of bones in the foot and ankle. The devices are provided non-sterile and require steam sterilization before use.

The subject device offers the same diameters and lengths as predicate devices with equivalent head and thread designs. The key technological difference is the addition of fully threaded screw diameters to increase bone purchase and strength, whereas the predicate devices are only partially threaded. Both subject and predicate devices are titanium alloy cannulated screws provided non-sterile for steam sterilization.

ASTM F543 was used for torsional properties testing, driving torque testing, and axial pullout strength testing. Additional testing included steam sterilization and cleaning (reprocessing) analysis and biological evaluation per biocompatibility standards.

Mechanical testing per ASTM F543 demonstrated that the subject screws perform equivalent to predicate screws despite the addition of fully threaded configurations. The technological differences do not raise new questions of safety or effectiveness. Steam sterilization and cleaning analysis confirmed the subject screws are compatible with Vilex's validated reprocessing instructions. Biological evaluation confirmed biocompatibility for the intended use. The identical indications for use and equivalent mechanical performance to legally marketed predicates establish substantial equivalence.