Spinal cage

Intended purpose

The ELSA® spacer and InterContinental® Plate-Spacer System are stand-alone lateral 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). The ELSA® spacer and InterContinental® Plate-Spacer System are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws and/or anchors which accompany the implant. The InterContinental® Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.