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The 4STM SPINAL SYSTEM is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bon 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 4STM SPINAL SYSTEM 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 impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The 4STM SPINAL SYSTEM is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, bolt, and a transverse (cross) linking mechanism. The 4STM SPINAL SYSTEM will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The 4STM SPINAL SYSTEM implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4STM SPINAL SYSTEM.