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The Ventana® A Anterior Lumbar Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Ventana® A Anterior Lumbar System is intended for patients who have had at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

The Ventana® A Anterior Lumbar Interbody System may be used as a standalone device when used with three integrated fixation screws and has a lordotic angle of 20° or less. When an interbody device with fewer than three screws is used, supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated fixation.

The Ventana® A Anterior Lumbar Interbody System is an integrated intervertebral body fusion device for use in lumbar spinal surgery. Ventana® A Anterior Lumbar Interbody System devices are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The devices include a lid which further facilitates the installation of bone graft.

The interbody devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001 and machined titanium alloy (Ti-6Al-4V ELI) components conforming to ASTM F136. The interbody device includes three screw holes to accept bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems.

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