DevicePMAs@therightstef:P050010_S000 JSONTXT 11 Projects

Approval for the prodisc-l total disc replacement. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l3-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients should have no more than grade 1 spondylolisthesis at the involved level. Patients receiving the prodisc-l total disc replacement should have failed at least six months of conservative treatment prior to implantation of the prodisc-l total disc replacement.