PathLoc Lumbar Interbody Fusion Cage System

The PathLoc Lumbar Interbody Fusion Cage System is a titanium alloy spinal implant designed for intervertebral body fusion in skeletally mature patients with degenerative disc disease at one or two contiguous levels from L2-S1. The hollow rectangular implants can be expanded in height after insertion and feature serrations for fixation; they are used with bone graft and supplemental fixation systems.

The device is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136), offered in various widths, lengths, heights and lordotic angles. It features serrations on superior and inferior surfaces and can be expanded in height using system instrumentation. The implants are substantially equivalent to the predicate in materials, design, indications for use, and mechanical performance.

ASTM F2077-18 (static and dynamic axial compression, compression-shear, and torsion testing) and ASTM F2267-04 Reapproved 2018 (static subsidence testing). These standards evaluated mechanical properties including compression, shear, torsion, and subsidence behavior.

The subject device is substantially equivalent to the PathLoc Lumbar Interbody Fusion Cage System (K213441) predicate because both share identical materials (Ti-6Al-4V ELI), design characteristics, indications for use, and operational principles. Bench testing demonstrated the subject device achieved higher or similar mechanical values compared to the predicate across all ASTM test parameters, with no new worst-case failures, supporting equivalence in safety and effectiveness.