ProAM ALIF System

The ProAM ALIF System is an intervertebral body fusion device made of titanium alloy for spinal fusion procedures at one or two contiguous levels of the lumbosacral spine in skeletally mature patients with degenerative disc disease, degenerative spondylolisthesis, and/or spinal stenosis. It consists of a fusion device with integrated fixation using bone screws, impacted screws, or curved anchors, and is used with autograft and/or allogeneic bone graft following at least six months of nonoperative treatment.

The device features a somewhat oval cross-section, box-shaped structure with cavities for bone graft, an open porous architecture, and a pyramidal textured porous surface at endplate contact surfaces to prevent migration. It is available in multiple configurations for direct anterior (ALIF) or oblique-anterior (OLIF) insertion with varying footprint sizes, heights, and lordotic angles (≤20° for certain standalone use). Fixation options include bone screws, impacted screws, and curved anchors, all manufactured from titanium alloy conforming to ASTM F136.

Static and dynamic cantilever testing per ASTM F2193 and expulsion testing were performed.

The ProAM ALIF System is substantially equivalent because it has identical indications for use as the predicate devices, uses the same material composition (titanium alloy), shares the same fundamental design approach and function as an integrated interbody fusion device, and demonstrated equivalent or superior mechanical performance in cantilever and expulsion testing compared to the predicates. The addition of impacted screws and curved anchors as fixation options represents a variation in fixation method within the same device category and functional intent.