GoLIF! Lumbar Interbody Fusion System

The GoLIF! Lumbar Interbody Fusion System is a sterile implantable cage device with instruments designed to be inserted into the intervertebral space of the lumbar spine (L1-L2 to L5-S1) to restore biomechanical integrity and promote fusion. It is indicated for patients with symptomatic degenerative disc disease, with or without up to Grade 1 spondylolisthesis, who have failed six months of conservative treatment and are skeletally mature. The implants are used with supplemental posterior fixation and bone graft and can be implanted via open, minimally invasive, or transforaminal approaches.

The device features implants in lengths of 22mm and 26mm, heights of 8-14mm in 1mm increments, and 10mm width. It has a tapered tip for distraction upon insertion, superior and inferior surface teeth to resist expulsion and migration, and a dome shape providing 7-18 degree lordosis. Openings allow bone graft packing. Instruments are manufactured from polyacrylamide (IXEF), polybutylene terephthalate (PBT), and medical-grade stainless steel.

Mechanical testing per ASTM F2077 (static and dynamic axial compression, static and dynamic compression shear), subsidence per ASTM F2267, and expulsion testing were performed. Limulus Amebocyte Lysate (LAL) testing per ANSI/AAMI ST72 confirmed endotoxin levels do not exceed 20 EU per device.

The GoLIF! device is substantially equivalent to the NuVasive CoRoent Lumbar System (Large Platform, K151472) because both serve the same intended use for lumbar interbody fusion with supplemental fixation and bone graft. They share the same technological characteristics in design (cage-based interbody implants), intended use (lumbar fusion for degenerative disc disease), material composition, function, and sterilization methods. Performance testing demonstrated mechanical properties comparable to the predicate device, and any identified technical differences do not introduce new questions of safety or effectiveness.