Orthofix Medical announced that more than 60,000 M6-C™ artificial cervical discs have been implanted worldwide. The implant is a next-generation artificial disc designed to mimic the natural motion of a native disc and provide an alternative to cervical fusion. First approved for distribution under the CE Mark in the European Union and other international geographies, the M6-C disc received FDA approval in 2019.
The M6-C disc is comprised of an artificial visco-elastic nucleus and fiber annulus. Like a natural disc, this unique construct allows for shock absorption at the implanted level and provides a controlled range of motion as the spine bends and translates in multiple planes. The M6-C disc is the only such device available in the U.S. with these features.
In August 2021, Orthofix announced the first patient implant in a U.S. Investigational Device Exemption two-level study of the M6-C disc. The study is evaluating patients treated for cervical degenerative disc disease at two contiguous vertebral levels with the M6-C disc compared to anterior cervical discectomy and fusion for symptomatic cervical radiculopathy.
“The M6-C artificial cervical disc is continuing to establish a market-leading position globally with more than 60,000 devices implanted worldwide,” said Orthofix President of Global Spine Kevin Kenny. “We are pleased to see the continued adoption of this state-of-the-art technology as our international success translates into the U.S. market.”