Orthofix announces FDA approval for M6-C Artificial Cervical Disc

Orthofix Medical announced FDA approval of the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The M6-C artificial cervical disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018. “With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients,” said Orthofix President and CEO, Brad Mason. “In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity ELITE allograft, a market-leading allograft developed in partnership with MTF Biologics. The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth.” Orthofix expects to release the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The M6-C artificial cervical disc received CE Mark approval for distribution in the European Union and other international geographies in 2006 and there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.

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