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The ATEC Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12. Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies The ATEC Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

ATEC Universal Spacer System includes the Battalion Universal Spacer System and Porous Ti Spacer System. The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants come in three material varieties: polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy (Ti-6Al-4V ELI). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The Porous Ti Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are made of a commercially pure porous titanium (PTi). The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the PTi implant is offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136, and the commercially pure titanium conforms to ASTM F67. All implants will be provided sterile.

The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12. Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in the following two material varieties: - Polyetheretherketone (PEEK) with tantalum markers - Commercially pure titanium coated polyetheretherketone (PEEK) with tantalum markers. . All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580. All implants are provided sterile. This system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of these instruments are made of surgical grade stainless steel (17Cr-4Ni) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before each use.

The NuVasive® CoRoent Thoracolumbar Implants are devices indicated for the following: Intervertebral Body Fusion The NuVasive CoRoent Thoracolumbar Implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. Thoracic Spine: The CoRoent Thoracolumbar Implants are intended for use for thoracic interbody fusions at one or two contiguous levels in the thoracic spine, from T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar Spine: The CoRoent Thoracolumbar Implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Partial Vertebral Body Replacement The NuVasive CoRoent Thoracolumbar Implants may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (TI to LS) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The implants are intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw system) that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The CoRoent Thoracolumbar Implants are manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracolumbar spine. This Special 510(k) is for additional implant offerings for use in the thoracic spine.