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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 Spinal System is a posterior. non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal seements 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 Spinal 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 Pedicle Screw System is a permanent implant device made from a titanium alloy TI 6AL4V-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 30-55mm. Rods are available in 5.5mm diameter, as either straight rods available in lengths from 30-500mm or precurved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, a cap and cross connectors to complete the assembly.

The CapLOX II Spinal 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 Spinal 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 Captiva Spine CapLOX II Spinal System is a top-loading spinal fixation system consisting of polyaxial pedicle screws, cannulated polyaxial pedicle screws set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy. The purpose of this submission is to add additional screws to the pedicle screw system.

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. Captiva Spine FuseLox 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 System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

The Pivotec LIFD implant 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 Pivotec LIFD Implant 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 Pivotec LIFD 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 of PEEK-Optima with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant within the intra-vertebral disc space.