Cervical total disc replacement prosthesis

Intended purpose

The Simplify Disc is indicated for use in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy for cervical degenerative disc disease defined as intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to an abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes or dark disc), and/or visible loss of disc height as compared to adjacent levels. Patients receiving the Simplify Disc should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g. numbness or tingling) or have signs of nerve root compression prior to implantation. The Simplify Disc is implanted via an open anterior approach.