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The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion. The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-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. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is an implant device made from a titanium alloy (Ti-6Al-4V-ELI) and Cobalt Chrome. The subject device is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 4.5mm and in lengths from 25mm – 120 mm. Titanium Alloy and Cobalt Chrome rods are available in 4.75mm – 6.0mm diameters either straight or pre-curved in lengths from 25-600 mm. Transition rods are also included with a tapered diameter from 4.75mm -5.5mm and lengths of 60mm - 600mm. The system also includes locking set screws, cross-links connectors, standard, reduction and Long polyaxial tulip heads along with the associated instrumentation to complete the procedure and implant construct.