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. FFX® is intended to provide temporary fixation and stabilization to the cervical spine as an adjunct to posterior cervical fusion (PCF) through bilateral immobilization of the facet joints and is only intended to be used in combination with an anterior cervical discectomy and fusion (ACDF), at the same level(s), in up to 3 consecutive levels of the cervical spine (C3-C7). FFX is indicated for skeletally mature patients with degenerative disc disease (DDD). DDD is defined as radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies. FFX® is to be used with autogenous bone and/or allogenic bone graft. Class II medical device, manufactured by SC MEDICA, France (510(k) clearance K250679). 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 before use.
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