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Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) 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 Atlas Spine Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Atlas Spine Spacer 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 of time. The interior of the Atlas Spine Spacer can be packed with autograft and/or allograft. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

The Atlas Spine Spacer is a rectangular, radiolucent device provided in various sizes. The device design includes six radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.

The Atlas Spine Pedicle Screw System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Atlas Spine Pedicle Screw System is a titanium alloy (6Al-4V ELI per ASTM F136) device consisting of a variety of non-sterile, single use components. The system consists of an assortment of polyaxial and monoaxial screws, cross connectors, rods, collar assemblies, offset receptacle bases and straight receptacle bases.

The Atlas Spine Vertebral Body Replacement (VBR) is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectorny) 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 Atlas Spine VBR is also indicated for treating fractures of the thoracic and lumbar spine. The Atlas Spine VBR 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 of time. The interior of the Atlas Spine VBR can be packed with bone. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

The Atlas Spine VBR is a rectangular, radiolucent vertebral body replacement device designed to replace, in whole or in part, a thoracic or lumber vertebral body after complete or partial vertebrectomy. The device design includes radiopaque markers that allow postoperative radiographic confirmation of the device position and orientation.