PathLoc Lumbar Plate System

The PathLoc Lumbar Plate System is a spinal fixation device consisting of titanium alloy plates and screws designed to stabilize the lumbar and lumbosacral spine (L1-S1). It is indicated for use via anterior surgical approach as an adjunct to fusion in treating spine instability from fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities, spinal stenosis, or failed previous spine surgery.

The system consists of plates and fixation screws manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136 standards, along with manual surgical instruments commonly used in general surgical procedures. The design features, materials, intended use, operational principles, and indications for use are substantially equivalent to the predicate devices.

Mechanical testing was conducted in accordance with ASTM F717 and FDA guidance document 'Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway.' Test values were compared against acceptance criteria outlined in the FDA guidance.

The subject PathLoc Lumbar Plate System was determined to be substantially equivalent to the predicate devices (AccelFix and Binary Lumbar Plate Systems) with respect to technical characteristics, performance, and intended use. Mechanical test results demonstrated that the PathLoc system met or exceeded acceptance criteria specified in the FDA guidance, establishing that it meets mechanical safety requirements comparable to the predicate devices.