Spinal Motion KINEFLEX-C

Clinical Investigation of the Kineflex|C Cervical Spinal System

Sponsor: SpinalMotion

This FDA approved investigational study evaluates the safety and effectiveness of the Kineflex-C artificial cervical disc for single-level surgical treatment of cervical spine disc disease. This is in comparison to a current standard treatment, an anterior cervical discectomy and fusion (ACDF) utilizing allograft bone and an anterior cervical plate. The goal is to have a success rate with the Kineflex-C that is no worse than a conventional ACDF.

Enrollment has ended, and the patients are in long-term follow-up. An application has been sent to the FDA by SpinalMotion, the study sponsor, for approval of the device.