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When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic, lumbar and sacral level. When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic and lumbar level. When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below. Posterior pedicle systems are 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 neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

General system description. The SCS Spinal System includes implantable components which fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system for each of three defined intended uses and to fit the patient's anatomical and physiological requirements. Materials. Materials for components of the SCS Spinal System are implant grade materials of titanium or stainless steel. The materials comply with applicable standards shown below: Titanium Alloy ASTM F136-92 ISO 5832-3 Titanium ASTM F67 GR2-95 ISO 5832-2 316LVM ASTM F138 GR2 ISO 5832-1 The system components include: Lumbar, thoracic, and pedicular hooks Vertebral screws, open vertebral screws, set screws, and pedicle screws (including self-locking) Rods in various lengths Connectors with set screws (sacral, anterior, transverse, lateral) Connecting elements (longitudinal connectors) Instruments Sterilizer trays