Lumbar total disc replacement prosthesis

Intended purpose

The TRIUMPH™ Lumbar Disc is comprised of a implant assembly inserted using an anterior approach. The assembly consists of a superior and inferior endplate with keels and a moving polyethylene core. The implant is offered in a variety of configurations to accommodate varied patient anatomy. The TRIUMPH™ Lumbar Disc is indicated for spinal arthroplasty in treating skeletally mature patients with degenerative disc disease, primary or recurrent disc herniation, spinal stenosis, or spondylosis in the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies, with or without leg (radicular) pain. Patients may have spondylolisthesis up to Grade 1 at the involved level.