No, Mobi-C is not considered experimental. In 2013, Mobi-C was approved for use in the U.S. by the Food and Drug Administration (FDA). Mobi-C has been successfully used in hundreds of U.S. hospitals and in thousands of U.S. patients to date, and over 70,000 global implantations.
To gain approval, Mobi-C underwent a rigorous prospective, randomized, multi-center clinical study. You can find Mobi-C’s letters of approval on the FDA’s website, at the following links:
Before being implanted in people, Mobi-C was tested in a lab. One industry standard test looked at implant wear. The wear test measured Mobi-C’s medical grade polyethylene insert for changes to size and weight after movement. To mimic the natural motion of the neck, the test used the combined movements of:
- Side bending (lateral bend).
- Forward-to-back bending (flexion-extension).
- Turning left-to-right (rotation).
Every Mobi-C tested in the lab completed 10 million movement cycles, all demonstrating low wear rates. During this testing there were:
- No mechanical failures.
- No significant damage to the polyethylene insert or the metal plates.
- No major biomechanical issues.
Mobi-C was then implanted and studied in patients. The testing data and two years of patient clinical data were reviewed by the FDA as part of the Mobi-C approval process in the U.S.
ZimVie cannot predict the Mobi-C life expectancy for each patient. However, Mobi-C has been implanted over 70,000 times, in the U.S. since 2006 and in Europe since 2004.