|Trade Name||LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE|
|Classification Name||intervertebral fusion device with bone graft, lumbar|
|Generic Name||intervertebral fusion device with bone graft, lumbar|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the lt-cage peek lumber tapered fusion device, which is manufactured from polyetheretherke-tone, with the trade name of peek-optima lt1. The device, as modified, will be marketed under the trade name lt-cage peek lumbar tapered fusion device and is indicated for spinal fusion procedures in skeletally mature patients with degernerative disc disease (ddd) at one level from l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Lt-cage peek implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the lt-cage peek lumbar tapered fusion device should have at least six months of non-operative treatment prior treatment with the lt-cage peek device.