INDICATIONS:
USA Law restricts this device to sale by or on the order of a physician. The FacetFuse MIS Screw System is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration
of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/ or instability on plain flexion extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.




