Lumbar Spine Truss System - Plating Solution (LSTS-PS)

The Lumbar Spine Truss System Plating Solution (LSTS-PS) is a spinal fixation device comprised of lumbar plates and screws with rotating locking tabs to prevent screw back-out. It is designed to provide temporary stability during lumbar fusion (L1-S1) for conditions including degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, pseudoarthrosis, and failed previous fusion. The plates are available in integrated and non-integrated configurations and can be used as supplemental fixation via lateral, anterolateral, or anterior surgical approaches.

The LSTS-PS plates have rotating locking tabs for each screw position and are available in 1-hole, 2-hole, and 4-hole integrated configurations plus 2-hole and 4-hole non-integrated configurations in multiple lengths. This submission adds smaller plate sizes and expands the integrated plates for use with 4WEB's Anterior Spine Truss System interbody fusion devices. Screws are available in two diameters and various lengths to accommodate patient anatomy.

Static axial compression bending, static torsion, dynamic axial compression bending fatigue, and axial screw pushout per ASTM F1717 and F543; static and dynamic axial compression and compression shear per ASTM F2077. Additional dynamic compression shear testing per ASTM F2077 was conducted with the LSTS-PS plates combined with the Anterior Spine Truss System interbody fusion device.

4WEB demonstrated substantial equivalence by comparing the LSTS-PS devices to predicate devices (primary: K203065; reference: Zimmer Biomet Lanx K131547) in indications for use, materials, function, and sizes. The smaller plate sizes and use with the anterior spine truss system do not represent a new worst case, as prior testing established adequate strength and performance. Non-clinical testing confirms the strength is sufficient for intended use and substantially equivalent to legally marketed predicates.