Prodisc Tm-C Total Disc Replacement

Approval order statement

APPROVAL FOR THE PRODISC-C TOTAL DISC REPLACEMENT. THE DEVICE IS INDICATED FOR SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE SYMPTOMATIC CERVICAL DISC DISEASE (SCDD). SYMPTOMATIC CERVICAL DISC DISEASE IS DEFINED AS NECK OR ARM (RADICULAR) PAIN AND/OR A FUNCTIONAL/NEUROLOGICAL DEFICIT WITH AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, OR X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR LOSS OF DISC HEIGHT. THE PRODISC-C TOTAL DISC REPLACEMENT IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE PRODISC-C TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-C TOTAL DISC REPLACEMENT.