Locking Plates and Screws Systems

The Locking Plates and Screws Systems is an orthopedic bone fixation device consisting of metallic locking plates, locking screws, and non-locking screws made from titanium (TA3G per ASTM F67) and titanium-alloy (TC4 per ASTM F136). It is intended to provide rigid fixation during fractures, fusions, and osteotomies across multiple bone sites including the clavicle, small bones (metacarpals, wrist, metatarsals, tarsals, phalanges), and long bones (radius, ulna, humerus, olecranon, fibula, femur, tibia).

The device uses titanium and titanium-alloy materials conforming to ASTM F67 and F136, with color anodized surface finish and non-sterile delivery state. It includes multiple plate configurations (lengths 16.5–482 mm) for different anatomical sites and screws ranging 1.5–7.5 mm diameter and 2–150 mm length. The plates are divided into ordinary and limited-contact types, representing standard orthopedic locking plate technology.

ASTM F382 (Static Four-Point Bending for metallic bone plates), ASTM F543 (Driving torque, torsional strength, and axial pullout testing for metallic bone screws), ISO 17665-1 (Sterilization validation for moist heat), and ISO 10993-1 (Biocompatibility evaluation per risk management process).

The subject device meets substantial equivalence because it has identical intended use (bone fixation via rigid osteosynthesis), uses materials within the Safety and Performance Based Pathway enumerated range (TA3G and TC4 titanium alloys), employs the same consensus-standard testing methodologies (ASTM F382, F543) as predicate devices, and demonstrates mechanical performance test results that meet or match predicate device performance. All sterilization parameters and biocompatibility endpoints fall within established SPBP criteria, and differences in plate configurations and lengths do not affect fundamental safety or effectiveness.