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The XCage™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). XCage™ System Spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Ouroboros XCage™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1 and is intended for intervertebral lumbar fusion. The XCage™ Spacer consists of a Shell and a Shim component that are offered in a range of sizes to accommodate variation in patient anatomy. The Shell component is a rectangular frame with struts on all four sides that allow for insertion into the intervertebral body space in a non-expanded form, and subsequent expansion following the insertion of the Shim component. The Shim component has a tapered front end that inserts into and expands the Shell component to the desired vertical and horizontal dimensions. When fully inserted, the Shim locks within the Shell to provide structural stability for interbody fusion. An integrated "Core" in the Shell serves to anchor the delivery instrument during Shim insertion. Protrusions on the superior and inferior surfaces of the Spacer grip the adjacent vertebral endplates to resist expulsion. The XCage™ Spacer is to be filled with autogenous bone graft material. Once implanted, the XCage™ Spacer is designed to restore intervertebral disc height, provide anterior column support and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The XCage Interbody Fusion System includes: - 1. The spacer components: shell and shim - 2. A set of re-useable manual surgical instruments for delivery of the device - 3. 23 mm and 27 mm implant lengths - 4. 0 and 6 degrees lordotic angles on the implant The XCage™ shell is made from polyetheretherketone (PEEK) per ASTM F2026, and integrated tantalum radiographic markers per ASTM F560. The XCage™ Shim and Core are made from Titanium alloy per ASTM F136. The re-usable surgical instruments are made from stainless steel.