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When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint b) who are receiving fusions with autogenous graft only c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum. When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Cadence™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.

The Sulzer Spine-Tech RPX™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The RPX™ Cement Restrictor is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunction with PMMA cement.

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint b) who are receiving fusions with autogenous graft only c) who are having the device fixed or attached to the lumbar or sacral spine d) who are having the device removed after the development of a solid fusion mass When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral illiac attachment only. Hook and transverse of the Silhouette Spinal Fixation System are intended for posterior thoracic only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws and are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varying diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various configurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint b) who are receiving fusions with autogenous graft only c) who are having the device fixed or attached to the lumbar or sacral spine d) who are having the device removed after the development of a solid fusion mass When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients: - having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint - who are receiving fusions with autogenous graft only - who are having the device fixed or attached to the lumbar or sacral spine, and - who are having the device removed after the development of a solid fusion mass When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients: - having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint a) - who are receiving fusions with autogenous graft only b) - who are having the device fixed or attached to the lumbar or sacral spine c) - who are having the device removed after the development of a solid fusion mass d) When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine. loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation. pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.