FFX® is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care. FFX® must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine, an FDA-cleared intervertebral body fusion device and/or an FDA-cleared posterior lumbar pedicle screw and rod system and with autogenous and/or allogenic bone graft. The FFX® is a Class II medical device, manufactured by SC MEDICA, France (510(k) clearance K232468). The use of this device is restricted to licensed healthcare professionals. Contraindications include, but are not limited to, osteoporosis and spondylolisthesis ≥ grade II. Potential risks include, but are not limited to, device migration and misplacement. Always read the full Instructions for Use (IFU) provided with the product before use.
