Orthofix Medical’s M6-C artificial cervical disc secures FDA approval

For many patients with cervical disc degeneration, M6-C artificial cervical disc will serve to regain motion and return to their normal activities.

Orthofix Medical Inc., a multinational medical device provider whose business is centered around musculoskeletal products and solutions, recently announced that the U.S. FDA has approved of its M6-C™artificial cervical disc that has been designed to help patients suffering from cervical disc degeneration.

In April 2018 Orthofix acquired Spinal Kinetics which is the developer of the M6-C artificial cervical disc.

Brad Mason, Orthofix President and CEO has been quoted to say that the approval has led Orthofix to have the most comprehensive portfolio in the cervical spine products industry. Mason said that Orthofix offers CervicalStim™device which is the only therapy that provides cervical bone growth stimulation that is FDA-approved and Trinity ELITE® allograft, that is developed in collaboration with MTF Biologics and is a market leader in allografting. Addition of the M6-C artificial cervical disc to its line of posterior, anterior and interbody fusion cervical implants will effectively complement its existing spine portfolio and can therefore be considered a significant milestone in the execution of the company’s strategy to accelerate growth.

Reportedly, the M6-C artificial cervical disc is developed to substitute intervertebral disc damage caused by cervical disc degeneration. The device serves as an alternative to cervical fusion by restoring physiologic motion to the spine. The M6-C artificial cervical disc restores biomechanical function after the native disc is removed and works to reduce successive degeneration of adjacent vertebral segments.

Sources close to the matter suggest that the M6-C device is unique due to the fact that it is the only artificial cervical disc that incorporates an artificial fiber annulus and visco-elastic nucleus into its design and imitates natural disc anatomy. It acts like a natural disc and facilitates shock absorption and provides controlled range of motion.

Dr. Rick Sasso, chief of spine surgery at the Indiana University School of Medicine said that cervical disc degeneration is often caused by vertebral disc deterioration due to injury or damage caused by natural aging process. This leads to pain in the neck, arms, shoulders and hands as well as numbness and weakness in the arm or hands. He said that for many patients with cervical disc degeneration, M6-C artificial cervical disc will serve to regain motion and return to their normal activities.