Orthofix recognizes the importance of collecting data from centers around the globe as we continue to monitor the clinical performance and safety of the M6-C artificial cervical disc. Please see some of our key data points below.
Patient Focused.
Proven Results.
Real World Evidence
70,000+ Devices Implanted
The M6-C artificial cervical disc is designed to maintain the natural behavior of a functional spinal unit by replicating the biomechanical characteristics of the native disc. The M6-C disc has established a robust clinical history with over 70,000 devices implanted in over 20 countries.
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Over 15,000 Devices Have Been Implanted For More Than 10 Years
First introduced outside the U.S. in 2006, the M6-C disc has a significant clinical history. Of the 70,000 devices implanted globally:
- 40,000 discs have been implanted for more than 5 years
- 30,000 discs have been implanted for more than 7 years
- 15,000 discs have been implanted for more than 10 years
99% Device Survivorship at 10 Years
Results of a Kaplan Meier analysis of the M6-C™ artificial cervical disc based on 16 years of real world evidence suggest a global cumulative survivorship (percentage of implanted devices that are still intact and functional at a specific time period) of 99% at 10 years, consistent with other, proven, joint-arthroplasty devices such as hip and knee replacements.
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Independent Analysis
Orthofix has engaged an independent lab to thoroughly investigate all returned devices to better understand the science and long-term clinical performance of the M6-C disc. To the best of our knowledge, we are the only company that performs this type of in-depth analysis.
In FDA-mandated pre-clinical wear testing, the M6-C™ artificial cervical disc demonstrated very low rates of wear; in fact, reported rates were a fraction of the rates reported for other FDA-approved devices.
A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 sites in the U.S. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression. The M6-C disc received U.S. FDA approval in February 2019 based on the results of this study.
About the M6-C Artificial Cervical Disc
The M6-C artificial cervical disc is a next-generation intervertebral disc designed to restore physiologic motion to the spine and is indicated as an alternative to cervical fusion. The device is comprised of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level and provides a controlled range of motion when the spine transitions in its combined complex movements. The M6-C artificial cervical disc is the only disc available in the U.S. with these features.
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