FDA-Approved Artificial Discs | Dr. Kris Radcliff

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FDA-Approved Artificial Discs and Long-Term Results

Artificial disc replacement removes a worn or herniated disc and replaces it with a motion-preserving implant instead of fusing the bones together. For the right patient, it relieves arm or leg pain from a pinched nerve while keeping the neck or low back moving more naturally. Dr. Kris Radcliff has helped lead the research on disc replacement, including long-term results from FDA clinical trials.

What does FDA approval mean?

In the United States, an artificial disc must go through a randomized clinical trial and receive Premarket Approval (PMA) from the Food and Drug Administration before it can be used. Each approval is specific: it covers a particular device, part of the spine, and number of levels. Your surgeon should be able to tell you whether your planned operation is within the device’s FDA-approved use.

FDA-approved artificial discs

Neck (cervical). Several cervical discs are FDA approved, including prodisc C (2007), Secure-C (2012), Mobi-C (2013, one and two levels), Prestige LP (2014), M6-C (2019) and Simplify (2020 for one level, 2021 for two levels). In 2022, three newer prodisc C designs (Vivo, Nova and SK) were approved, and in 2025 prodisc C Vivo and SK were approved for one or two levels.

Low back (lumbar). Two lumbar discs are FDA approved: prodisc L (2006 for one level, 2020 for two levels) and activL (2015, one level).

Why Dr. Radcliff uses prodisc

Dr. Radcliff most often uses the prodisc family of discs because it has the longest track record of any artificial disc. Prodisc was first implanted in 1990 and, according to the manufacturer, more than 300,000 have been implanted worldwide. It is approved in the United States for one and two levels in both the neck and the low back, and several sizes and shapes allow the disc to be matched to each patient’s anatomy.

Dr. Radcliff also has experience with other designs. He was an investigator in the FDA clinical trial of the Simplify cervical disc, which is made of materials that cause less interference on later MRI scans.

What does the long-term research show?

Dr. Radcliff was first author of several of the major long-term reports from FDA trials:

In a seven-year randomized trial, cervical disc replacement held up well over time, with patient outcomes that compared favorably with fusion (study).
Patients whose replaced disc kept moving had less wear at the neighboring levels at seven years (study).
For two-level neck disease, disc replacement compared favorably with fusion at five years (study).
Seven-year results from a randomized lumbar disc trial showed lasting improvement (study).
Over seven years, prodisc C was found to be cost-effective compared with fusion (study).

Who is a good candidate?

Arm pain from a pinched nerve or a herniated disc in the neck, at one or two levels, that has not improved with nonsurgical care
Low back pain from one or two worn discs in carefully selected patients
Good bone quality and healthy joints at the back of the spine

Disc replacement is usually not the right choice for patients with significant arthritis of the facet joints, instability or slippage, weak bones (osteoporosis), or certain prior surgeries. In those cases, Dr. Radcliff may recommend another option, such as endoscopic surgery, facet replacement or fusion.

Insurance

Many commercial insurance plans cover cervical disc replacement. Coverage for lumbar disc replacement varies more by plan. Our team handles the prior authorization and reviews your coverage with you before surgery. Learn about insurance.

Find out if disc replacement is right for you

Call 609-800-3472, book online, or send your MRI for a review. See also: Artificial Disc Replacement, Disc Replacement vs. Fusion, Research and Clinical Trials.

Device approval dates are from FDA records and manufacturer announcements. This page is general education and not medical advice. Disclosure: Dr. Radcliff has served as an investigator or course faculty member for spine device companies, including makers of devices named on this page.