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The GSO GS1 Cannulated Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Cannulated Screw System should be removed after fusion. As a pedicle screw system, the GSO GS1 Cannulated Screw System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a pedicle screw system, the GSO GS1 Cannulated Screw System is indicated for 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). When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Cannulated Screw System is indicated for: 1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Idiopathic scoliosis 3. Kyphotic deformities of the spine 4. Paralytic scoliosis and/or pelvis obliquity 5. Vertebral fracture or dislocation 6. Neuromuscular scoliosis associated with pelvic obliquity 7. Vertebral fracture or dislocation 8. Tumors 9. Spondylolisthesis 10. Stenosis 11. Pseudarthrosis 12. Unsuccessful previous attempts at spinal fusion For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only.

The GSO GS1 Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. The current submission, the GSO GS1 Cannulated Screw System, adds the following components to the GSO GS1 System: 5.5mm and 1/4" straight longitudinal rods in lengths of 50 - 480mm; 5.5mm and 1/4" pre-bent rods in lengths of 30 - 120mm; and multi-directional cannulated screws with standard or reduction heads in diameters of 5.5mm - 8.5 and lengths of 25mm - 100mm (depending on the screw diameter) to fit either 5.5mm or 1/2" rods. These additional components are compatible with the previously cleared GSO GS1 rods, screws, hooks and connectors. The GSO GS1 Spinal System can be installed with any suitable instrumentation. The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6Al-4V Titanium alloy conforming to ASTM F136.

The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion. The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following: 1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Fracture or dislocation 5. Revision of previous cervical or cervico-throracic spine surgery 6. Tumors The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation. The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion. As a pedicle screw system, the GSO GS1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a pedicle screw system, the GSO GS1 Spinal System is indicated for 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). When used as a posterior, non-cervical, non-pedicle screw and/or hook fixation system, the GSO GS1 Spinal System is indicated for: 1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) 2. Idiopathic scoliosis 3. Kyphotic deformities of the spine 4. Paralytic scoliosis and/or pelvis obliquity 5. Vertebral fracture or dislocation 6. Neuromuscular scoliosis associated with pelvic obliquity 7. Vertebral fracture or dislocation 8. Tumors 9. Spondylolisthesis 10. Stenosis 11. Pseudarthrosis 12. Unsuccessful previous attempts at spinal fusion For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GS1 hooks and crosslinks are intended for thoracic and/or lumbar use only. In all cases, instrumentation must be at least 1 cm from any major vessel.

The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslink that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are a vophed to the spine posteriorly by means of screws and/or hooks joined with rods. Crosslink components are used to attach two rods in parallel. The GSO GS1 Spinal System can be installed with any suitable instrumentation. The GSO GS1 Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.