TITAN Nail; APTUS K-Wire System

The TITAN Nail is a titanium alloy cannulated compression screw used to treat bone fractures, osteotomies, and arthrodesis. The APTUS K-Wire System is a stainless steel device for bone fracture fixation, reconstruction, and as guide pins for implant insertion. Both devices are sterile implants available in multiple sizes and diameters.

The TITAN Nail is manufactured from titanium alloy per ASTM F136, cannulated, headless, and fully threaded, available in lengths of 12–80 mm and diameters of 2.2–4.0 mm. The APTUS K-Wire System is manufactured from stainless steel per ASTM F138, available in 100 mm length and 0.8 mm and 1.1 mm diameters, with double-ended trocar and offering sterile and X-ray beam sterilization options.

ASTM F136 (titanium alloy material standard) and ASTM F138 (stainless steel material standard). The devices conform to previously declared consensus standards within K232251 and K202589.

Both devices share identical intended uses, operating principles, basic designs, materials, and sterilization methods as their respective predicates (K232251 for TITAN Nail and K202589 for APTUS K-Wire System). Design-control impact assessment and existing verification and validation data confirm that modifications do not affect performance, safety, or effectiveness, demonstrating substantial equivalence.