FFX Facet Fixation System

The FFX Facet Fixation System is a bilateral facet joint stabilization device consisting of a titanium cage and compressive screw. It provides temporary fixation and stabilization to aid spinal fusion in the lumbar spine (L3-S1) for degenerative disc disease and in the cervical spine (C3-C7) as an adjunct to anterior cervical fusion, using autogenous and/or allogenic bone graft.

The FFX system uses titanium construction (cage and screw per EN ISO 5832-3) for long-term implantation in multiple size options. It operates on the same principles as the predicate device, providing bilateral facet joint immobilization through a posterior surgical approach with similar materials and single-patient, single-use design.

ASTM F2077 (static and dynamic shear testing), EN ISO 5832-3 (titanium material specification). Biocompatibility and sterilization validation testing were also completed.

The FFX is substantially equivalent to the PMT PCSS predicate because both devices provide fixation and stabilization as an adjunct to spinal fusion using similar titanium materials and design principles, with comparable intended use and performance across multiple size options. The device demonstrated equivalence through non-clinical testing (biocompatibility, sterilization, bench testing) and clinical data.