|Trade Name||LT-CAGE 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|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a revised laparoscopic surgical technique for implantation of the lt-cage. The device remains marketed under the trade name lt-cage tapered fusion device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level form l2-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Lt-cage implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the lt-cage lumbar tapered fusion device should have had at least six months of nonoperative treatment prior treatment with the lt-cage.