Orthofix Implants First Patient with M6-C Artificial Cervical Disc in Study

Orthofix Medical has completed the first patient implant in a clinical study to evaluate the safety and effectiveness of its M6-C artificial cervical disc.

Designed to restore motion to the spine as an alternative to cervical fusion, the artificial disc gained FDA approval in 2019 for single-level implantation from the C3 to C7 vertebrae.

The clinical trial, which the Lewisville, Tex.-based company is conducting under an investigational device exemption from the FDA, will evaluate 263 patients who are being treated at two vertebral levels either with the M6-C disc or with discectomy and fusion.