X-PAC® N-GAGE™ Lumbar Plate System

The X-PAC® N-GAGE™ Lumbar Plate System is a spinal fixation device comprising titanium plates, screws, couplers, and instruments used in lateral or anterolateral interbody fusion surgery. It provides rigid stabilization between vertebrae during fusion procedures for conditions including degenerative disc disease, spondylolisthesis, trauma, and deformity across thoracic, thoracolumbar, and lumbosacral spine levels in skeletally mature patients.

The device consists of 1-hole, 2-hole, and 4-hole plate configurations made from medical-grade titanium alloy per ASTM F136, with fully threaded screws available in two diameters and multiple lengths. Screws can be angled up to 20 degrees away from the cage and 10 degrees toward it. Each screw hole has an adjacent locking tab, and the system includes a coupler for secure connection to interbody devices. The plate design conforms to spinal curvature with a flat, elongated shape.

ASTM F1717-21 (static and dynamic compression bending, static torsion); ASTM F543-23 (torsion, driving torque, axial pullout of bone screws); ASTM F2077-22 (static and dynamic axial compression, compression shear of interbody fusion devices); plus retention feature strength and screw pushout testing.

The X-PAC® N-GAGE™ operates via the same mechanism of action as the SeaSpine Regatta Lateral System predicate—both consist of plates and screws manufactured from identical material (titanium alloy) and are designed to provide rigid spinal stabilization. The indications for use are substantially similar across both systems. Performance testing demonstrates equivalent mechanical behavior under compression, torsion, and shear loading. Differences in technological characteristics (design details, configurations) do not affect overall performance and safety profiles.