ARx® SAI Implant System

The ARx® SAI Implant System is a thoracolumbosacral pedicle screw system consisting of implants in various lengths and diameters with associated instruments. It is intended for sacroiliac joint fusion in conditions including sacroiliac joint dysfunction, degenerative sacroiliitis, fractures, and as an adjunct to thoracolumbosacral fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, spinal tumor, pseudarthrosis, and failed fusion.

The device consists of a bone screw, head, and taper lock assembled during manufacturing and is designed for connection to compatible 5.5 mm or 6.0 mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods. It can be placed in sacral alar iliac (SAI) trajectories, iliac trajectories, and S1 pedicle positions. Dimensional comparison and mechanical testing were performed to demonstrate compatibility with commercially available representative rods.

Static axial grip per ASTM F1798, static torsional grip per ASTM F1798, and dynamic compression bending per ASTM F1717. The device is also subject to ISO 13485 design controls, nonconforming product procedures, corrective action, and preventative action requirements.

The ARx® SAI Implant System was shown to be substantially equivalent to predicate devices (Life Spine ARx SAI K241464, Life Spine Sacroiliac Joint Fixation Screw System K141246, and SI-Bone iFuse Bedrock Granite K233508) in indications for use, design, function, materials used, and mechanical performance. Dimensional comparison to predicates and mechanical testing on various rod diameters and manufacturing methods demonstrated compatibility and performance equivalence.