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The LUX Expandable Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). LUX Expandable Lumbar Interbody System implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The LUX Expandable Lumbar Interbody System implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Xenix Medical LUX™ Expandable Lumbar Interbody System implants are manufactured using Titanium Alloy (Ti-6AL-4V ELI per ASTM F136 and F3001). Implants are available in a variety of footprints and geometric options to fit the anatomical variations of patients. The implants are provided sterile. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NANOACTIV™ micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10⁻⁹) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document. In vitro results may not be representative of clinical performance. Note: Supporting Study Data will be provided upon request.

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