Indications for use

The ALIF system is indicated for use 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 patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The ALIF system 10°-20° lordotic cages may be used as a standalone system. The ALIF system 25°-40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The ALIF system implants can also be used as an adjunct to fusion in patients diagnosed with multi-level degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF system must be used with a supplemental internal spinal fixation system (e.g. pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.