ORIO Ti Cage System - Spinal cage

Intended purpose

This system is ind icated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. This system is to be used with supplemental fixation that has been cleared/approved for use in the cervical spine. These hyperlordotic intervertebral body fusion cervical cages (≥10°) are required to be used with an anterior cervical plate as the form of supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. This system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This system is to be used with autogenous bone or allograft bone comprised of cancellous and/or corticocancellous bone. This system is to be used with supplemental spinal fixation systems that have been cleared/approved for use in the lumbosacral spine. These hyperlordotic intervertebral body fusion lumbar cages (≥20°) should be used with anterior supplemental fixation (e.g., an anterior lumbar plate). Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.