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The CapLOX II® / TowerLOX® MIS Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® MIS Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

The CapLOX II® / TowerLOX® MIS Pedicle 4.5mm Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to be implanted from the posterior approach. The screws are currently available in diameters from 4.9-9.0mm and in lengths frOm 30-100mm. The line extension will include the addition of 4.5mm screws for the CapLOX II® /TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additional instrumentation will also be added to the system. Overall, the system includes pedicle screws, and the instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.

The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a titanium alloy and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: lordotic, anatomically correct and parallel

The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is made from a titanium alloy (Ti-6Al-4V ELI per ASTM F3001 and TI-6Al-4V ELI per ASTM F136) and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: PLIF (Lordotic; 3°, 6°, and 15°, Convex) and TLIF (Straight, Curved Lordotic and Curved Parallel)

The CapLOX II® / TowerLOX® Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX II® / TowerLOX® Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

The CapLOX II® / TowerLOX® MIS Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to be implanted from the posterior approach. The screws are currently available in diameters from 4.9-9.0mm and in lengths from 30-100mm. The line extension will include the addition of 4.9-9.0mm extended tab screws to be marketed as TowerLOX® EXT MIS Extended Tab Pedicle Screws in lengths of 30-100mm. All screws with a 5.5mm, 6.5mm and 7.5mm screw diameters will have an updated tip angle. The set screws currently have a 5mm hex, will also be available with a T25 Torx interface. Additional instrumentation will also be added to the system. Overall, the system includes set screws, pedicle screws, and rods with the associated instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.

The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. When used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), or who are having the device removed after the attainment of a solid fusion.

The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and pre- lordosed configurations. The system includes set screws, pedicle screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and prelordosed configurations. The system includes set screws, and rods alone with the associated instrumentation to complete the procedure and implant construct.

The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screwretaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length. The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.

The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. FuseLOX Cervical IBF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation. The Captiva Spine FuseLOX Cervical IBF is intended to provide mechanical support of the cervical spine while biologic fusion occurs. It is intended to be used with supplemental fixation.

The Captiva Spine FuseLOX Cervical IBF System includes various size implants manufactured from implant grade PEEK-OPTIMA'™ LT1 conforming to ASTM F2026-12. The devices also have radiopaque markers made from either titanium alloy (Ti6Al4V) per ASTM F136 or tantalum per ASTM F560-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and pre-lordosed configurations. The system includes set screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The FuseLOX Lumbar Interbody Fusion System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made from PEEK-Optima with tantalum or titanium markers. The devices are provided in lordotic and convex configurations with heights ranging from 7-14mm in 1mm increments. Each device has a hollow core to receive bone graft. Placement is achieved with a series of device specific instruments provided.