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As a pedicle screw system, it is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium. As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are: 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 pelvic obliquity. 5. Lordotic deformities of the spine. 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 levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.

The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. The posterior application components are grouped as follows: 1. INTEGRAL TM Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS). 2. Open and Closed Spinal Hooks with Sliders, C-Rings and Set Screws. 3. Adjustable and Fixed Transverse connectors with Set Screws. 4. Closed and Axial Rod Connectors with Set Screws. 5. Lateral Connectors with Set Screws. 6. Rods. 7. Instruments. 8. Sterilizer case(s). The anterior application components are grouped as follows: 1. INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws. 2. Vertebral Washers. 3. Fixed Transverse Connectors with Set Screws. 4. Rods. 5. Instruments. 6. Sterilizer case(s). Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).

As a pedicle screw system, it is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; © who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium. As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications are: 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 pelvic obliquity. 5. Lordotic deformities of the spine. 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 levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.

The SYNERGY™ Spinal System is intended to be used a part of a temporary construct that assists normal healing and is not intended to replace normal body structures. It is intended to help stabilize the spinal operative site during fusion procedures. It attaches to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. The posterior application components are grouped as follows: 1. INTEGRALTM Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with Variable Locking Seats, and Iliac Screws, with Hex Nuts and Set Screws. Only the INTEGRALTM Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation (see INDICATIONS). 2. Open and Closed Spinal Hooks with Sliders, C-Rings and Set Screws. 3. Adjustable and Fixed Transverse connectors with Set Screws. 4. Closed and Axial Rod Connectors with Set Screws. 5. Lateral Connectors with Set Screws. 6. Rods. 7. Instruments. 8. Sterilizer case(s). The anterior application components are grouped as follows: 1. INTEGRAL™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws. 2. Vertebral Washers. 3. Fixed Transverse Connectors with Set Screws. 4. Rods. 5. Instruments. 6. Sterilizer case(s). Material: The implantable components may be made from either titanium or stainless steel. The titanium version consists of surgical implant grade titanium alloy as described by ASTM Standard F136 (Ti 6A1-4V ELI), and commercially pure titanium, grade 2 as described by ASTM Standard F67 (CP Ti, Gr. 2). The stainless steel version consists of surgical implant grade stainless steel as described by ASTM standard F1314 (22-13-5 Stainless Steel), and surgical implant grade stainless steel as described by ASTM standard F138, Grade 2 (316L Stainless Steel).