CanMINI Hand and Foot System

The CanMINI Hand and Foot System is an orthopedic fixation system consisting of titanium and titanium alloy bone plates and screws designed to stabilize fractures and osteotomies of small bones in the hand and foot. The system provides mechanical support during bone healing by maintaining proper alignment and stabilizing the fracture site. It is supplied non-sterile, must be sterilized before use, and is intended for single use only.

The device uses pure titanium (ASTM F67) and titanium alloy (ASTM F1472) in various plate and screw configurations including straight plates, non-locking supporting plates, and locking supporting plates in sizes ranging from 1.5mm to 3.5mm. Minor differences from predicates include different dimensions, variations in hole numbers, and specific material specifications, but these do not raise new safety or effectiveness questions.

ASTM F67-13 (unalloyed titanium material composition), ASTM F1472-23 (titanium alloy composition), ASTM F382-24 (single cycle bend testing for plates), and ASTM F543-23 (axial pullout strength and driving torque/torsional properties for bone screws).

The device demonstrates substantial equivalence by adhering to the FDA's Safety and Performance Based Pathway through compliance with established ASTM material and mechanical performance standards. Since the subject device meets FDA-identified performance criteria via these consensus standards, it requires no further direct substantial equivalence comparison to predicates. The minor dimensional and design variations do not introduce new questions of safety or effectiveness given the device's conformance to the same performance standards as the predicate devices.