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When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients (MN), The AMT Spinal™ System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine (1) severe degenerative spondylolithesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudoarthrosis). The AMT Spinal™ Svstem is intended for skeletally mature patients (MNH): (1) having severe spondylolithesis (Grades 3 and 4) at the L5-S1 vertebral joint; (2) who are receiving fusion by autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The AMT Spinal™ System is designed for use as a construct system and consists of set screws, hex nuts, hooks, rods, screws, and cross link assembly (cross link rod and connecting hook) which can be variously assembled to provide immobilization of the thoracic. lumbar, and lumbosacral spine. The system is composed of the following components: right hand set screw, left hand hex nut, pedicle screw, polyaxial screw, rod, cross link assembly (cross link rod and connecting hook). All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). The components under review are the Polvaxial screws. Polyaxial upper body head, and concave compression washer. The AMT Polyaxial Pedicle Screw serves as an additional option to the pedicle screw configurations currently offered in the AMT Spinal™ System (K002059). in a construct system. The AMT Polyaxial Pedicle Screw utilizes the same straight forward simple instruments and is identical to the pedicle screws currently offered in the AMT Spinal™ System in the all areas with the exception of the following: The top loading polyaxial head allowing for greater positioning abilities. - The rotating head (polyaxial) eliminates the need to bend rods for constructs up to the . three (3) vertebral levels. - The rotating head (polyaxial) can be rotated allowing the surgeon greater versatility in ● positioning rod and screws to the anatomy. - Allows anatomical screw placement and easy rod positioning. ● - This allows the surgeon multi-angle pedicle screw insertion. . - All components are made from Wrought Titanium 6Al4V ELI Alloy (ASTM F-136). Materials: Function: The system functions to assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine.