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The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GSFS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium allov. Ti6A14V that conforms to ASTM 136 98 and include pedicle screws, hooks, rods, cross link, and connector. Various sizes of these implants are available. Specialized instrument made from surgical instrument grade stainless steel is available for the application and removal of the GSFS implants.