|Trade Name||DUAL INTERFIX-RP(TM) THREADED 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 use of dual interfix-rp(tm) threaded fursion devices (instead of the already approved use of a single interfix-rp(tm) threaded fusion device used in conjunction with an interfix(tm) threaded fusion device) the unmodified device will continue to be marketed under the trade name interfix-rp(tm) threaded fusion device and is indicated for spinal fusion procedures in skeletally mature patients wtih 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. Interfix-rp(tm) threaded fusion devices are to be used with autogenous bone graft and implanted via an open anterior approach. Patients receiving the interfix-rp(tm) threaded fusion devices should have had at least six months of nonoperative treatment prior to treatment with the interfix-rp(tm) threaded fusion device.