DevicePMAs@therightstef:P040006_S000 JSONTXT 11 Projects

Approval for the charite artificial disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-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 3 mm of spondylolisthesis at the involved level. Patients receiving the charite artificial disc should have failed at least six months of conservative treatment prior to implantation of the charite artificial disc.