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The Atlas Spine Lateral Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiquous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectory for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

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 Atlas Spine Lateral Expandable Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Atlas Spine Lateral Expandable Interbody System spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Atlas Spine Lateral Expandable Interbody System), a generic "Indications for Use" form, and information about the Paperwork Reduction Act.

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