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When used as vertebral body replacement, the ATLAS Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone grafting material. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time. When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to S1. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation. For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.

This submission is intended to seek clearance for a product line extension to the ATLAS Spinal Cage VBR. The extension includes the addition of 8mm, 10mm, 12mm, 14mm, and 16mm cages to the current offering. Additionally adding the product code MAX for Intervertebral body fusion devices CFR 21 888.3080. The Spinal Edge ATLAS Intervertebral Body Cage is an Intervertebral Body Cage device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each cage has an axial hole to allow grafting material to be packed inside. Protrusions on the superior and inferior surfaces of the device will grip the cortical endplates of the adjacent vertebrae and resist expulsion. The Spinal Edge ATLAS Intervertebral Body Cage components are available in titanium alloy conforming to ASTM F-136 specifications.

The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system(s) that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support for a prolonged period of time even in the absence of fusion.

The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow optional grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the cortical endplates of the adjacent vertebrae to resist expulsion