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FFX is a lumbar facet system that is placed bilaterally through a posterior surgical approach and spans the facet interspace with the component FFX screw through the component FFX facet cage. FFX is intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability from L3 to S1 in skeletally mature patients who have failed conservative care.

The FFX Facet Fixation system consists of an FFX Cage and an FFX Facet Screw.

The cage component of the FFX implant is a sterile, single patient use, long-term implantable device made of titanium. The cage has a D-shape that is designed to be packed with autogenous and/or allogenic bone graft. The top and bottom surfaces of the cage have teeth to improve fixation to the bone. The cage contains a bullet nose to ease insertion.

FFX Cages are titanium devices available in several sizes to ensure proper fit in the facet joint space. The implant is positioned between the facet joints, with its apex oriented anteriorly. The cage is surgically placed in the facet joint in combination with autogenous and/or allogenic bone graft material inside and posterior to the implant. Two devices are used per level with the FFX screw through the cage lumen. They are implanted between the two facets to be stabilized and can contain autogenous and/or allogenic bone graft.

The FFX Facet Screw is a self-compressive, self-tapping, headless and cannulated screw with a continuous progressive thread. It is made of titanium alloy (EN ISO 5832-3). It is provided sterile and intended for long-term implantation.

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