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# Orthofix Artificial Cervical Disc Approved
- URL: https://www.fdaweb.com/orthofix-artificial-cervical-disc-approved/
- Published: 2019-02-08T12:00:00.000Z
- Updated: 2026-09-15T01:02:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143336

FDA has approved an Orthofix Medical PMA for the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The device was developed by Spinal Kinetics, a company acquired by Orthofix 4/2018\. The next-generation artificial disc is designed to restore physiologic motion to the spine, and it is indicated as an alternative to cervical fusion. It “preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments,” according to the company. “The M6-C device is the only artificial cervical disc that mimics the anatomic structure of a natural disc by incorporating an artificial visco-elastic nucleus and fiber annulus into its design.”

Approval was based on clinical trial data that showed 90.5% of patients who received the M6-C disc demonstrated a meaningful clinical improvement under a “Neck Disability Index,” Orthofix says. Additionally, it showed a meaningful clinical improvement in arm pain score in 91.2% of the M6-C disc patients compared to 77.9% in control patients.