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When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine. When used as a lumbar intervertebral fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

The basic shape of the Cervical and Lumbar GPS™ devices is a structural column having upper and lower implant openings and a central cavity for autograft bone. The cervical devices have a "B" shaped cross-section. The PLIF devices are rectangular having a pyramidal anterior surface. The TLIF device cross-section is curved having a wedged leading face. For all devices, surface teeth assist in the seating the implant between the vertebral bodies. Each device type is available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.