Who makes the M6 disc replacement?
The US Food and Drug Administration (FDA) has approved the M6-C artificial cervical disc (Orthofix Medical) for patients suffering from cervical disc degeneration. The artificial disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018.
Who is eligible for disc replacement?
Artificial disc replacement may be recommended for patients between the ages of 18 and 60 with DDD at one or two levels of the spine whose condition has not responded to at least six previous months of non-surgical therapy.
What is the best cervical disc replacement?
Types of Disc Replacements
- Prodisc-C. For patients who require a total cervical disc replacement and who qualify, Prodisc-C is an advanced option that has several key benefits over other TDR and spinal fusion procedures.
- Mobi-C Cervical Disc.
- Medtronic Prestige LP.
- M6-C Artificial Cervical Disc.
Is cervical disc replacement FDA approved?
The devices allow motion by smooth, usually curved, surfaces sliding across each other. Cervical Artificial Disc Replacement has been FDA-approved since 2007.
What is the M6 C?
The M6-C 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 spine’s natural structure and movement, including backward and forward, side to side, up and down, and rotate left and right.
Who is not a candidate for disc replacement?
Advanced degenerative changes known as spondylosis affecting the facet joints in the back of the spine at the affected level also precludes the use of a disc replacement device. A disc replacement device should also not be used in the presence of significant osteoporosis or an active infection.
Is M6 disc FDA-approved?
Yes, the M6-C disc was approved by the U.S. FDA in February 2019 for use in treating single-level cervical disc degeneration. For more information about the approval, read the news release.
What is the difference between spinal fusion and disc replacement?
The key differences between artificial disc replacement and spinal fusion surgery is that artificial disc replacement surgery offers the advantages of being reversible, and avoids the accepted shortfalls of the traditional spinal fusion surgery. With artificial disc replacement techniques there is no fusion of the motion segment in the spine.
What is an artificial disc replacement?
Artificial Disc Replacement. Artificial disc replacement is a surgical procedure in which a degenerated disc in the spine is replaced with a mechanical device that substitutes as an artificial version in an effort to restore motion. It is most commonly performed to treat degenerative disc disease or post-laminectomy syndrome in patients who do not…
What is a disc replacement?
Disc replacement is defined as removal of the damaged organic intervertebral structure and subsequent substitution of a synthetic disc unit, which may be a single or multi-piece prosthetic device. This is not to be confused with disc nucleus replacement, in which only in the interior portion of the organic disc is treated.