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M6-C ARTIFICIAL CERVICAL DISC

The M6-C disc is the only disc designed with a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of the natural disc. This unique product is designed to mimic your spine's natural structure and movement, including backward and forward, side to side, up and down, and rotate left and right.

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Meet Our Spine Surgeons Performing the M6-C Procedure

Nicholas Renaldo, MD

Nicholas Renaldo, MD

Orthopedic Spine Surgeon

See How the M6-C Cervical Disc Works!

  • The M6-C artificial cervical disc is an innovative next-generation option for patients needing artificial disc replacement as an alternative to spinal fusion. This unique product is designed to mimic your cervical spine's natural structure and movement, including backward and forward, side to side, up and down, and rotate left and right.
  • During an artificial disc replacement procedure, a small incision is made in the front of the neck to remove the ruptured or herniated disc. Once the damaged disc is removed and the pinched nerve is relieved, your doctor will then place the M6-C artificial disc into the same disc space between vertebrae to maintain the disc space height, as well as retain motion at the treated level. After the M6-C disc is successfully placed using specialized instruments, the incision is closed.
  • Like many new medical devices available in the U.S., the M6-C disc was evaluated through a large Investigational Device Exemption (IDE) clinical study to ensure the device was safe and effective prior to making it available to surgeons. This data was the basis for the U.S. Food and Drug Administration (FDA) approval in February 2019 of the M6-C disc for patients suffering from cervical disc degeneration.
  • Overall, patients in the study receiving the M6-C disc reported a 92-percent satisfaction rate with the surgery, and 93 percent said they would have the surgery again.

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WHEN DID THE M6-C ARTIFICIAL CERVICAL DISC RECEIVE APPROVAL?

Orthofix Medical Inc. announced U.S. Food and Drug Administration (FDA) approval of the M6-C artificial cervical disc for patients suffering from cervical disc degeneration in early February 2019. The M6-C disc received CE Mark approval for distribution in the European Union and other international geographies in 2006. There have been more than 45,000 implants of the M6-C disc outside of the U.S. to date.

WHAT IS CERVICAL DISC DEGENERATION?

Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many patients with cervical disc degeneration, spine surgeons have used the M6-C disc to replace the patient's damaged disc with one that closely mimics their natural disc, enabling the patient to regain motion and return to their normal activities.

HOW COMMON IS NECK PAIN?

More than one third of a billion people worldwide had neck pain in 2015, according to studies summarized by the Global Spine Care Initiative and published by the National Institutes of Health1. In addition, more than 1.5 billion people worldwide suffer from chronic pain; neck pain (15%) is the third most common type of chronic pain2. Throughout the world, the pain and disability associated with chronic neck pain have a large impact on individuals and their families, communities, healthcare systems and businesses.

WHO DEVELOPED THE M6-C ARTIFICIAL CERVICAL DISC?

The M6-C disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018. Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. Orthofix's mission is to improve patients' lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix's spine and orthopedic extremities products are distributed in more than 70 countries via the company's sales representatives and distributors. For more information, please visit www.orthofix.com.