FFX Facet Fixation System

The FFX Facet Fixation System is a lumbar spine implant consisting of a titanium cage and a titanium alloy screw. It is placed bilaterally through a posterior surgical approach to immobilize facet joints at one or two levels (L3 to S1) with bone graft, providing temporary fixation and stabilization as an aid to lumbar fusion in skeletally mature patients with degenerative disc disease or facet disease who have failed conservative care.

The device comprises a D-shaped titanium cage with toothed surfaces for bone fixation and a self-compressive, self-tapping, headless, cannulated titanium alloy screw (EN ISO 5832-3) with continuous progressive thread. The cage is designed to hold autogenous and/or allogenic bone graft and is available in multiple sizes for proper facet joint fit.

ASTM F543 (axial pullout testing), plus sterilization, cytotoxicity, shelf-life, static torsion, and driving torque testing per bench testing protocols. EN ISO 5832-3 cited for screw material specification.

The FFX is substantially equivalent to its primary predicate (SC Medica FFX K232468) and additional predicate (PMT FFS-LX K230840) based on similar indications for use, technological characteristics, materials (titanium and titanium alloy), packaging, and sterilization methods. Bench and clinical testing data demonstrate comparable safety and performance to legally marketed predicates.