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The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

InterGro® DBM products contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. Some versions contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 to 10 um outer layer of calcium phosphate. InterGro DBM products have been processed aseptically and are ready to use. They do not require rehydration or any special preparation. InterGro DBM is intended for single patient use only.

The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and ncural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

The Titanium Mesh Implant is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67). The sides of the cylinder implants contain concentric oval patterned openings. These openings allow the surgeon to trim the cylinder to the desired length at a pre-specified angle relative to the longitudinal axis of the cylinder. The external surface of the implant contains concentric circular grooves perpendicular to the axis of the cylinder which provides a guide in the event that a perpendicular end is desired.

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for: - . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) - Spondylolisthesis . - Spinal stenosis t - . Fracture/dislocation - . Atlantoaxial fracture with instability - Occipitocervical dislocation . - Revision of previous cervical spine surgery - . Tumors The occipital bone screws are limited to occipital fixation only. The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

The C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The C-TEK C-Thru Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole or slotted hole design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

The C-TEK Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C2 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy. The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The C-TEK Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole (C-TEK and C-TEK C-Thru) or slotted hole (C-TEK) design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a pedicle screw system, the Synergy Spinal System 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; (c) 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. In addition, the pedicle screw system may also be used 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, and failed previous fusion (pseudarthrosis). As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System 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. - Kyphotic deformities of the spine. 3. - Paralytic scoliosis and/or pelvic obliquity. - Lordotic deformities of the spine. - Neuromuscular scoliosis associated with pelvic obliquity. 6. - Vertebral fracture or dislocation. 7. - 8. Tumors. - 9. Spondylolisthesis. - 10. Stenosis. - 11. Pseudarthrosis. - 12. Unsuccessful previous attempts at spinal fusion. For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium. The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery. For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

The Synergy™ Spinal System components are grouped as follows: Posterior Application: - Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with 1. Variable Locking Seats and Iliac Screws with Hex Nuts and Set Screws. Caution: Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation. - Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 2. - Adjustable and Fixed Transverse Connectors with Set Screws. 3. - 4. Closed and Axial Rod Connectors with Set Screws. - Lateral Connectors with Set Screws. 5. - Rods and Adjustable Length Rods and Set Screws. 6. - 7. Instruments. - 8. Sterilizer case(s). Anterior Application: - 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). NOTE: While the Variable Locking Screws and some fasteners (nuts and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters. NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery. The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies) - Spondylolisthesis . - ◆ Spinal stenosis - ◆ Fracture/dislocation - Atlantoaxial fracture with instability . - . Occipitocervical dislocation - . Revision of previous cervical spine surgery - . Tumors The occipital bone screws are limited to occipital fixation only. The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bonc screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.