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The Interwedge® Standalone Lateral is a standalone lateral lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Interwedge® Standalone Lateral is to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone, and is to be used with the two titanium alloy screws which accompany the implant. Should a physician choose to use fewer than these two screws, additional supplemental fixation must be used to augment stability.

The Interwedge® is a lateral standalone intervertebral body fusion device in the lumbosacral spine (L1-S1) intended to provide stability and promote fusion between adjacent vertebrae.

The Interwedge® consists of the intravertebral wedge (or spacer) with a lateral plate and a contralateral staple. The lateral plate, with two or four bones screw options, and the contralateral staple provide the integrated fixation to the construct. The Interwedge device is offered in a range of implant sizes and heights to cater to different patient anatomy. The spacer, lateral plate, and staple components will be additively manufactured from Ti-6A1-4 ELI per ASTM F3001. The sub-components of the staple mechanism and the integrated fixation screws will be machined from Ti-6Al-4V ELI per ASTM F136. A cover plate which is attached to the lateral plate after insertion of the bone screws is manufactured from Ti-6Al-4V ELI per ASTM F136.

This document does not contain an AI/ML device, therefore, the information requested in your prompt is not available in the provided text. The document refers to a medical device called "Interwedge® Standalone Lateral," which is a spinal intervertebral body fixation orthosis. The provided text is a 510(k) premarket notification for this device, outlining its indications for use, technological characteristics, and performance data, all of which are related to a physical implant and not a software algorithm or AI model.

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