X-PAC® LLIF Expandable Lateral Cage System

The X-PAC® LLIF Expandable Lateral Cage System is a lumbar interbody fusion device for treating degenerative disc disease at one or two contiguous spinal levels (L2-S1) in adults. The titanium cage is placed laterally between vertebrae to provide structural support, distraction, and promote bone fusion, and must be used with supplemental fixation and bone graft materials.

The subject and predicate devices are identical in intended use, materials (medical-grade titanium alloy per ASTM F136 and F1472), manufacturing, operating parameters, and instrumentation. Both feature toothed surfaces for stability, fenestrated design for bone ingrowth, and intraoperative height adjustability via a lateral approach.

ASTM F2077-22 Standard Test Methods for Intervertebral Body Fusion Devices, including static and dynamic axial compression, static and dynamic compression shear, expulsion and subsidence testing (ASTM 2267), and wear analysis. Testing also referenced Class II Special Controls Guidance for Intervertebral Body Fusion Devices.

The subject device is substantially equivalent because it is identical to the predicate (K223174) in indications for use, design, materials, manufacturing processes, and surgical technique. Non-clinical mechanical performance testing demonstrated equivalent or superior results to predicate data across all tested parameters, confirming the device meets pertinent standards and performs as intended without presenting new safety or effectiveness concerns.