Orthofix Medical Inc. 10.13.21
Orthofix Medical Inc., a global medical device company with a spine and orthopedics focus, 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. Developed to replace an intervertebral disc damaged by cervical disc degeneration, the M6-C disc is indicated as 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 U.S. Food and Drug Administration (FDA) approval in 2019.
“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.”
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 of 2021, Orthofix announced the first patient implant in a U.S. Investigational Device Exemption (IDE) 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 (ACDF) for symptomatic cervical radiculopathy.
Orthofix Medical Inc. is a global medical device with a spine and orthopedics focus. The company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic products are distributed in more than 60 countries via the company's sales representatives and distributors.
“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.”
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 of 2021, Orthofix announced the first patient implant in a U.S. Investigational Device Exemption (IDE) 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 (ACDF) for symptomatic cervical radiculopathy.
Orthofix Medical Inc. is a global medical device with a spine and orthopedics focus. The company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic products are distributed in more than 60 countries via the company's sales representatives and distributors.