Cervical Total Disc Replacement: Food and Drug Administration-Approved Devices.

The first US Food and Drug Administration (FDA) approval for cervical total disc replacement (CTDR) was issued in 2007. Since then, 8 more artificial discs have been granted FDA approval for single-level CTDR. Two of these have also been approved for 2-level CTDR. All devices are indicated for levels C3 to C7 for symptomatic patients with radiculopathy or myelopathy caused by disc herniation or spondylosis unresponsive to conservative management. Trials have shown noninferiority of CTDR compared with anterior cervical decompression and fusion in their overall success. Hybrid surgery and CTDR of 3 or more levels are not FDA approved.