HEDRON Lumbar Spacers - Spinal cage

Intended purpose

HEDRON™ Lumbar Spacers (HEDRON A™, HEDRON L™, HEDRON P™, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation(with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. HEDRON™ Lumbar Spacers are to be filled with autogenous bone graft material, bone graft extenders, and/or bone graft substitutes. These devices are intended to be used with supplemental fixation systems for use in the thoracolumbosacral spine(e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or more contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). HEDRON IA™ Spacers are to be filled with autogenous bone graft material,bone graft extenders, and/or bone graft substitutes. These devices are intended to be used with any combination of three screws and/or anchors which accompany the implants. When used without screws or anchors, HEDRON IA™ Spacers may be used as anterior lumbar interbody fusion devices to be used with supplemental fixation.