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# Nuvasive Cervical Artificial Disc Approved
- URL: https://www.fdaweb.com/nuvasive-cervical-artificial-disc-approved/
- Published: 2021-04-06T12:00:00.000Z
- Updated: 2026-09-14T16:53:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149053

FDA has approved a NuVasive PMA for its Simplify Cervical Artificial Disc for two-level total disc replacement. Approval was based on data that demonstrated clinical superiority at 24 months compared to anterior cervical discectomy and fusion (ACDF) in a two-level IDE study, the company says. In the study, the device showed an overall success rate that was nearly 10% higher when compared to ACDF, it says, adding that a greater percentage of patients achieved success in a 15-point neck disability index and had no neurological deterioration components in relation to fusion.

The device is made of PEEK on ceramic materials that allow for enhanced visualization through MRI postoperatively compared to alternative devices, Nuvasive says. It is anatomically designed and includes 4mm, 5mm, and 6mm options.