ORIO-3D Cage System

The ORIO-3D Cage System is a set of titanium alloy intervertebral body fusion devices for spinal fusion surgery. It includes cervical cages for neck fusion, lumbar TLIF/PLIF cages for lower back fusion, and ALIF cages that can be used standalone with bone screws or with supplemental fixation. The devices are packed with bone graft material to promote spinal fusion in patients with degenerative disc disease, instability, or deformity.

The devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Class C. They feature windows to accommodate bone graft, textured superior and inferior surfaces with teeth to resist expulsion and migration, and are available in multiple sizes and lordotic angles. The ORIO-3D ALIF cages can optionally integrate with ANTERIS bone screws for standalone use.

ASTM F2077-22 (axial compression, shear-compression, torsion testing), ASTM F2267-04 Reapproved 2018 (subsidence), ASTM F1877-16 (particle analysis), MED-SPN-EXP 2nd Edition Rev. 0 (expulsion), and ASTM F3001 (material specification).

The ORIO-3D Cage System is substantially equivalent to predicate devices because it has the same indications for use, material composition, intended function, and mechanical performance. Comparison to multiple predicate devices (Eminent Spine 3D, BAK/C Vista, HEDRON, CONSTRUX, Lucent, Modulus ALIF) established substantial equivalence through identical design principles, function, and favorable non-clinical mechanical testing results.