Southern Craniomaxillofacial (CMF) System

The Southern Maxillofacial (MF) System is a plate and screw fixation system made from titanium and titanium alloy, designed to stabilize and immobilize bone segments during maxillofacial, midface, and mandibular surgeries. It is intended for osteotomy, reconstruction, and fracture fixation procedures.

The device consists of Grade 2 commercially pure titanium plates (ASTM F67) in multiple styles and thicknesses (0.2–1.5 mm) and Ti-6Al-4V ELI titanium alloy screws (ASTM F136) in various diameters and lengths with self-tapping or self-drilling options. Both plates and screws feature anodized surfaces and are non-sterile. The system offers plate styles including straight, curved, L-plates, T-plates, Z-plates, and orbital floor plates, with screw diameters ranging from 1.5 to 2.3 mm and lengths from 4 to 16 mm.

The device was tested using ASTM F382 (bone plate static and dynamic four-point bending), ASTM F543 (screw axial pullout, torsional breaking force, and insertion torque).

The Southern MF System is substantially equivalent to the Optimus CMF System (primary predicate, K140037) because it employs identical materials, surface treatments, and technological characteristics with comparable plate styles and screw specifications. Performance testing demonstrates mechanical strength equivalent to the predicate, with minor differences in available dimensions and styles that do not raise new safety or effectiveness concerns.