Ventana™ A Anterior Lumbar Interbody System

The Ventana® A Anterior Lumbar Interbody System is an integrated spinal fusion device for lumbar surgery in skeletally mature patients with degenerative disc disease at one or two levels (L2–S1). It is used with bone graft and may serve as a standalone device with three integrated fixation screws when the lordotic angle is 20° or less; otherwise, supplemental fixation is required.

The device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, with machined titanium components per ASTM F136. It features multiple footprints with varying lengths, widths, heights, and lordotic angles, an internal graft aperture with a removable lid, and three screw holes to accept titanium alloy bone screws in various sizes.

ASTM F2077 (static and dynamic axial compression and compression shear testing), ASTM F2267 (subsidence testing), ASTM F1877 (wear particle characterization), and screw pushout testing, all performed per FDA Class II Special Controls Guidance for Intervertebral Body Fusion Devices.

The Ventana® A is substantially equivalent to its predicates (Optimus ALIF System and others) because it is identical or similar in intended use, device description, technological characteristics, and non-clinical performance. Mechanical testing demonstrates the same performance characteristics as the predicate devices.