|Trade Name||LORDOTEC(TM) 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 a tapered version of the interfix(tm) threaded fusion device. The device, as modified, will be marketed under the trade name lt-cage(tm) tapered fusion device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative 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 may also have up to grade i spondylolisthesis or retrolisthesis at the involved level. Lt-cage(tm) implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the lt-cage(tm) lumbar tapered fusion device should have had at least six months of nonoperative treatment prior to treatment with the lt-cage(tm).