Leforte MMF System

The Leforte MMF System is a bone plate and screw fixation system designed for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during healing. It consists of titanium plates affixed to the jaw bones using screws, with optional wire or elastic interconnections, and is indicated for adults and adolescents age 12 and older with erupted permanent teeth.

The subject device uses pure titanium plates (ASTM F67) and titanium alloy screws (ASTM F136). It differs from the predicate in plate thickness (0.8 mm vs 0.5 mm), length dimensions, screw hole count (13 vs 9), and offers non-locking screws in addition to locking and MMF screws. All screws are self-drilling with 2.0 mm thread diameter and lengths of 6–12 mm.

ISO 17665-1 and ISO 17665-2 for sterilization validation; ASTM F67 and ASTM F136 for material specifications; ASTM F382 for 4-point bending and fatigue testing of plates; ASTM F543 for torsion, driving, and axial pull-out testing of screws; ISO 10993-1 for biocompatibility evaluation.

The subject device has identical indications for use and same product codes as the predicate (K122313). Although design and dimensional differences exist, comparative bench testing demonstrated equivalent mechanical performance in hook strength, 4-point bending, fatigue, and screw performance tests. The fundamental structural design, materials, and intended function are substantially equivalent, with no new safety or effectiveness concerns raised by the design variations.