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6 Cervical Artificial Discs, Their Features, and Clinical Proof Points

Published March 26, 2021
| Written By SpineNation Editorial Staff   | Medically Reviewed by Benjamin Bjerke, M.D.
If you have cervical degenerative disc disease that hasn’t responded to non-surgical management, your doctor may recommend surgery. 

One surgical option is cervical artificial disc replacement, also known as total disc replacement. With this method, a surgeon removes the damaged disc and replaces it with an artificial disc

This procedure is designed to relieve nerve compression that is causing pain, numbness, weakness or tingling in the neck and arms. At the same time, the artificial disc maintains the motion at the repaired spinal level.

There are currently several cervical artificial disc replacement technologies on the market. Choosing the right one can help you recover more quickly and regain your quality of life — whether that means getting back to work or resuming your usual physical activities.

To help you make an informed decision, we've put together a list of six cervical artificial disc implant technologies. All of these have undergone clinical testing in the United States and have received full approval by the U.S. Food and Drug Administration (FDA).

Although cervical artificial disc technologies are a relatively newer surgical option compared to anterior cervical discectomy and fusion (ACDF), two-year follow-up after surgery shows that both procedures give similar results.

It is still too early, though, to recommend one specific artificial disc device over the others. However, before making your choice, it is useful to understand how these devices work and which patients they are well-suited for.

Methodology

What do we mean by FDA approval?

Medical devices marketed in the United States are regulated by the FDA. Before a device can be sold on the market, the FDA has to review it to make sure that it is safe and effective for consumers.

Not all medical devices are the same when it comes to risk, though. Plastic bandages and stethoscopes have different risks than implantable devices like pacemakers and breast implants.

The FDA has three different categories of review for medical devices. Class III is for devices with a high risk to the patient or user. Implantable devices like artificial disc technologies fall under this category. 

Class III devices go through the most rigorous FDA review and approval process. Companies have to show the FDA that the device works and is safe. This involves testing the device in clinical trials in people. It can also include testing in animals beforehand.

Once a device has received FDA approval, it can be sold on the market. But this is not the end of the process. The FDA also requires companies to continue monitoring the device — to make sure it works as intended and that there are no serious complications or problems with the device.

What do we mean by mean wear rate?

Ideally, an artificial disc replacement technology would last for the lifetime of the person in which it is implanted. If the device wore out before then, it could mean additional surgery is needed or the device could cause harm to the person.

Companies that make artificial disc technologies test the devices in a lab to see how they will perform over the long run in people. This kind of wear testing involves bending the device in ways similar to how it would work in the spine after implantation. This testing is done with a load to simulate the weight of the body on the spine.

During testing, companies look at how the parts wear (e.g., do they develop cracks or deep grooves) and what kinds and size of particles are given off. Testing is usually done for 10 million cycles for each type of movement. This is equivalent to about 240 years, well past the lifetime of a patient. 


BRYAN-Cervical-Disc.jpgBRYAN Cervical Disc

FDA Approved: YES


Indication

The BRYAN Cervical Disc is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct a single damaged disc from C3 to C7.

The device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness in the arms due to a degenerated disc. They may or may not have neck pain. Patients should have tried 6 weeks of non-surgical treatment without success before undergoing implantation of the device.

Contraindications

The BRYAN Cervical Disc is not appropriate for patients with:
  • an active infection at the site where the device will be implanted
  • an allergy to any of the materials used in the device
  • low bone mineral density (osteoporosis)
  • serious instability in the cervical spine
  • serious deformity on the cervical spine at the location of the damaged disc
  • serious curvature of the spine (lordosis or kyphosis)
  • a need for treatment at more than one cervical level
The manufacturer has patient resources that provide the full range of indications and contraindications for the device. 

Summary

The FDA approved the BRYAN Cervical Disc in 2009. The safety and effectiveness of the device were studied in a multi-center, randomized clinical trial that compared the use of the BRYAN Cervical Disc to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion).

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • neck pain and disability
  • neurological symptoms like numbness, weakness or tingling
  • complications related to the device or surgery
  • need for additional surgeries to fix, adjust or remove the device
They also measured other factors, including neck and arm pain, patient satisfaction, and the results of medical imaging done on the cervical spine.

The average overall success rate for the BRYAN Cervical Disc after two years was 80.4 percent, compared to 71.8 percent for cervical fusion.

What Stands Out About the Device?

The BRYAN Cervical Disc is not attached to the adjacent vertebrae with screws but sits in pockets surgically made in the bone. Over time, the bone grows around the device to keep it fixed in place.

Approach/Insertion

The BRYAN Cervical Disc is inserted through the front (anterior) of the cervical spine. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the BRYAN Cervical Disc through 10 million cycles of wear testing, with loads and movements that simulated the natural functioning of the spine.

At the end of testing, the device showed no signs of damaged parts, deep cracks on the nucleus, large pieces of plastic breaking off from the nucleus, or more than minimal wear on the surfaces.

Based on durability testing, the company estimates that the device would last 295 years with normal use.

Device Material and Design

The BRYAN Cervical Disc consists of a plastic (polyurethane) nucleus that fits between two titanium shells, or endplates. Posts on the inner side of the endplates fit into holes in the nucleus in order to control the range of motion. The posts do not touch the nucleus.

A polyurethane sheath forms a compartment that protects the moving parts of the device. This sheath is injected with saline through a hole in one of the posts during implantation. The saline works as an initial lubricant for the moving parts of the device.

Fixation

The BRYAN Cervical Disc is not fixed to the vertebrae with screws. Instead, the outer sides of the endplates sit in pockets that are surgically made in the bony front part of the adjacent vertebrae. Beading on the outer side of the endplates encourages bone to grow around the fixed part of the device.

Degrees of Freedom and Biomechanics

During normal use, the device allows for 4.9 degrees of front and back movement of the spine at the level of the artificial disc, and 4.0 degrees side-to-side bending.



M6-C-Cervical-Disc.jpgM6-C Artificial Cervical Disc

FDA Approved: YES


Indication

The M6-C Artificial Cervical Disc is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct a single damaged disc from C3 to C7. It is designed to maintain and restore the motion at that level of the cervical spine.

The device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness in the arms due to a degenerated disc. They may or may not have neck pain. 

Patients should have tried six weeks of non-surgical treatment without success before undergoing implantation of the device, or have worsening symptoms after undergoing non-surgical therapies. 

Contraindications

The M6-C Artificial Cervical Disc is not appropriate for patients with:
  • a deformity (unnatural shape) of the spine at the level of the degenerated disc or at the level above or below
  • advanced abnormal changes in the spine at the level of the damaged disc
  • advanced degeneration in the rear (posterior) spinal joints
  • infection at the site of the operation or elsewhere in the body
  • low bone mineral density (osteoporosis)
  • allergy to any of the materials used in the device

Summary

The FDA approved the M6-C Artificial Cervical Disc in 2019. The safety and effectiveness of the device was studied in a multi-center, randomized clinical trial that compared the M6-C Artificial Cervical Disc to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion). 

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • neck pain and disability
  • complications related to the device or surgery
  • need for additional surgeries to fix, adjust or remove the device
  • changes in neurological symptoms such as weakness or numbness in the arms
They also measured other factors, including neck and arm pain, quality of life, use of pain medication, time it took to return to work, and the results of medical imaging done on the cervical spine.

The average overall success rate for the M6-C Artificial Cervical Disc after two years was 85.7 percent, compared to 78.9 percent for cervical fusion. 

What Stands Out About the Device?

The M6-C Artificial Cervical Disc has an artificial polymer nucleus (core) and an artificial fiber annulus situated between two pairs of endplates (outer and inner). This allows the artificial disc to replicate the motion of a natural disc.

Approach/Insertion

The M6-C Artificial Cervical Disc is implanted using an anterior approach. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the M6-C Artificial Cervical Disc through 10 million cycles of wear testing, with loads and movements that simulated the natural functioning of the spine.

At the end of the testing, there was only a small amount of debris created by device wear. Testing also showed that the device was “robust” when subjected to conditions that would likely occur during normal use, as well as to some more extreme conditions.

No information on the life span of the device was provided by the company.

Device Material and Design

The M6-C Artificial Cervical Disc consists of two titanium alloy inner endplates that are welded to two titanium alloy outer endplates. The exterior surfaces of the outer endplates have several ridges, or fins, that anchor the device to the adjacent vertebrae. The exterior surfaces are also coated with titanium to increase the contact between the device and the bone.

In between the endplates is a core, or artificial nucleus, made of plastic (polycarbonate urethane polymer). Around this is wound a plastic fiber (ultra-high molecular weight polyethylene). The fiber is also threaded through slots in the endplates, but it is not fixed to it.

A plastic (polycarbonate urethane polymer) sheath wraps around the nucleus and fiber. This prevents tissue from growing into the fiber or nucleus, and debris from collecting there.

Fixation

The fins on the exterior surface of the outer endplates anchor the device to the bony back part (vertebral bodies) of the adjacent vertebrae. The fins fit into slots surgically carved in the bone. The exterior surface is also coated with titanium to encourage bone to grow and attach to the device.

Degrees of Freedom and Biomechanics

After two years, the M6-C Artificial Cervical Disc allowed for an average of 8.8 degrees forward and backward tilting of the head, compared to 1.16 degrees for cervical fusion.


Mobi-C-Cervical-Disc.jpgMobi-C Cervical Disc Prosthesis

FDA Approved: YES


Indication

The Mobi-C Cervical Disc Prosthesis is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct two adjacent damaged discs from C3 to C7. It is designed to maintain and restore the motion and disc height at that level of the cervical spine.

The device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness in the arms due to a degenerated disc. They may or may not have neck pain. 

Patients should have tried six weeks of non-surgical treatment without success before undergoing implantation of the device, or have worsening symptoms after undergoing non-surgical therapies.

Contraindications

The Mobi-C is not appropriate for patients with:
  • infection at the site of the operation or elsewhere in the body
  • allergy or sensitivity to any of the materials used in the device
  • damaged cervical vertebrae at the level to be operated on due to a previous injury
  • serious deformity or disease at the level to be operated on
  • serious instability in the cervical spine
  • low bone mineral density (osteoporosis or osteopenia)
  • serious degeneration or disease in the facet joints
The manufacturer has patient resources that provide the full range of indications and contraindications for the device. 

Summary

The FDA approved the Mobi-C in 2013. The safety and effectiveness of the device was studied in a multi-center, randomized clinical trial that compared the Mobi-C to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion). 

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • neck pain and disability
  • complications related to the device or surgery
  • need for additional surgeries to fix, adjust or remove the device
They also measured other factors, including neck and arm pain, patient satisfaction, quality of life, and the results of medical imaging done on the cervical spine.

The average overall success rate for Mobi-C after two years was 69.7 percent, compared to 37.4 percent for spinal fusion. 

What Stands Out About the Device?

The Mobi-C is designed to spare the bone of the adjacent vertebrae. This is done using teeth on the endplates of the device which sink into the bone of the vertebrae, rather than the surgeon having to chisel or remove part of the bone.

Approach/Insertion

The Mobi-C is implanted using an anterior approach. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the Mobi-C through 10 million cycles of wear testing, with loads and movements that simulated the natural functioning of the spine.

At the end of the testing, there was only minor wear, and no damage or failure of the device parts. All of the particles that wore off from the device were very small.

The company found that the wear of the device is similar to other cervical disc replacement technologies on the market. No information on the life span of the device was provided by the company.

Device Material and Design

The Mobi-C consists of two endplates made of cobalt, chromium, and molybdenum. The sides of the plates that contact the bone are sprayed with titanium and hydroxyapatite. A mobile insert that fits between the two plates is made of plastic (polyethylene).

The inner surface of the top plate is rounded, while the inner surface of the bottom plate is flat. This allows for greater contact between the plates and the mobile insert. The outside of the plates is sprayed with a coating that encourages the bone of the adjacent vertebrae to grow onto the plates.

Two stops on the sides of the bottom plate controls the movement of the mobile insert from side to side. Two rows of teeth on the plates enhance fixation and stability.

Fixation

The teeth on the outside of the plates sink into the bone of the adjacent vertebrae to keep the device in place. No chiseling or removal of the bone needs to be done.

Degrees of Freedom and Biomechanics

After two years, the Mobi-C allowed for an average of 10.1 degrees forward tilting of the head, 8.3 degrees backward tilting, and 5.4 to 5.5 degrees of side-to-side tilting. These were all greater than the range of motion for spinal fusion.


PCM-Cervical-Disc.jpgPCM Cervical Disc System

FDA Approved: YES


Indication

The PCM Cervical Disc System is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct a single damaged disc from C3-C4 to C6-C7.

The device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness due to a degenerated disc. They may or may not have neck pain. Patients should have tried six weeks of non-surgical treatment without success before undergoing implantation of the device.

Contraindications

The PCM Cervical Disc is not appropriate for patients with
  • A short- or long-term infection in the area of the surgery or the body
  • Low bone mineral density (osteoporosis or osteopenia)
  • A narrowing of the spinal canal since birth (congenital stenosis)
  • Allergy or sensitivity to any of the materials in the device
The manufacturer has patient resources that provide the full range of indications and contraindications for the device. 

Summary

The FDA approved the PCM Cervical Disc in 2012. The safety and effectiveness of the device was studied in a multi-center, randomized clinical trial that compared the PCM Cervical Disc to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion). 

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • Improvement in neck pain and function
  • Failures of the device that required alteration, re-operation or removal of the device
  • Absence of major complications
They also measured other factors, including neck and arm pain, patient satisfaction, quality of life, and the results of medical imaging done on the cervical spine.

The overall success rate of the PCM Cervical Disc after two years was 75.1 percent, compared to 64.9 percent for cervical fusion.

What Stands Out About the Device?

The PCM Cervical Disc has a low-profile design that minimizes disruption of the vertebrae adjacent to the device. It can also be used as a treatment for vertebrae adjacent to levels where spinal fusion was used before.

Approach/Insertion

The PCM Cervical Disc is implanted using an anterior approach. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the PCM Cervical Disc through 10 million cycles of wear testing with loads and movements that simulated the natural functioning of the spine.

At the end of testing, the device showed no signs of damage or failure of the parts. Particles that wore off from the surfaces were all very small.

No information on the life span of the device was provided by the company.

Device Material and Design

The PCM Cervical Disc consists of two endplates made of cobalt-chromium molybdenum, and a central core, or spacer, made of plastic (polyethylene). 

The core has a wide radius, which helps preserve the motion of that level of the cervical spine. The endplates are also wider, which enhances the stability of device against the front part of the adjacent vertebrae. 

The sides of the endplates that contact the bone are coated with two layers of titanium covered by a layer of calcium phosphate. This surface has ridges that enhance the fixation of the device to the bone after surgery.

Fixation

Three rows of v-shaped teeth on the endplates anchor the device to the adjacent vertebrae. Ridges on these surfaces encourage the bone to attached to the device and enhance its stability.

Degrees of Freedom and Biomechanics

After two years, the PCM Cervical Disc allowed for an average of 7.9 degrees of tilting the head forward and backward at the level of that was operated on. This was similar to the range of motion after cervical fusion.


Prodisc-C-Cervical-Disc.jpgProDisc-C Total Disc Replacement

FDA Approved: YES


Indication

The ProDisc-C Total Disc Replacement is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct a single damaged disc from C3-C7.

The device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness due to a degenerated disc. They may or may not have neck pain. 

Patients should have tried six weeks of non-surgical treatment without success before undergoing implantation of the device.

Contraindications

The ProDisc-C is not appropriate for patients with:
  • An infection in the body or at the surgery site
  • Low bone mineral density (osteoporosis)
  • Serious instability in the cervical spine
  • Allergy or sensitivity to any of the materials of the device
  • Severe disease, degeneration, deformity or instability in the cervical spine
  • Cervical degenerative disc disease at more than one level
The manufacturer has patient resources that provide the full range of indications and contraindications for the device. 

Summary

The FDA approved the use of the ProDisc-C in the cervical spine in 2007.

The safety and effectiveness of the device was studied in a multi-center, randomized clinical trial that compared the ProDisc-C to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion). 

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • neck pain and disability
  • neurological symptoms like numbness, weakness or tingling
  • need for additional surgeries to fix, adjust or remove the device
  • complications related to the device or surgery
They also measured other factors, including neck and arm pain, patient satisfaction, and the results of medical imaging done on the cervical spine.

The overall success rate of the ProDisc-C after two years was 77.2 percent, compared to 74.3 percent for cervical fusion.

What Stands Out About the Device?

The ProDisc-C is the only device that is designed to replace damaged discs in both the lumbar and cervical spine.

Approach/Insertion

The ProDisc-C is implanted using an anterior approach. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the ProDisc-C through 10 million cycles of wear testing, with loads and movements that simulated the natural functioning of the spine.

At the end of testing, the device showed no visible signs of wear. All of the particles that wore off from the device were very small.

No information on the life span of the device was provided by the company.

Device Material and Design

The ProDisc-C consists of three pieces — two endplates made of cobalt, chromium, and molybdenum; and a middle insert made of plastic (polyethylene).

The device works like a ball and socket. The plastic insert is attached to one plate and is shaped like a ball. This rounded surface fits into the other endplate, which has a curved socket.

Fixation

A raised ridge (keel) on the outer side of the endplates is inserted into a groove surgically made in the bone of the adjacent vertebrae. Titanium sprayed onto the surfaces that contact the bone encourage the bone to grow onto the device.

Degrees of Freedom and Biomechanics

After two years, the ProDisc-C allowed for an average of 9.4 degrees of tilting the head forward and backward.


SecureC-cervical-disc.jpgSECURE-C Artificial Cervical Disc

FDA Approved: YES


Indication

The SECURE-C Artificial Cervical Disc is intended for use in skeletally mature patients with degenerative disc disease in the cervical spine. The device can be used to reconstruct a single damaged disc from C3 to C7.

This device is appropriate for patients who have symptoms such as arm pain and/or weakness or numbness in the arms due to a degenerated disc. They may or may not have neck pain. 

Patients should have tried six weeks of non-surgical treatment without success before undergoing implantation of the device.

Contraindications

The SECURE-C is not appropriate for patients with:
  • An infection in the body or at the surgery site
  • Low bone mineral density (osteoporosis or osteopenia)
  • Allergy or sensitivity to any of the materials in the device
  • An unstable cervical spine
  • Advanced arthritis in the cervical spine at the level of the damaged disc
  • Severe disease, degeneration, deformity or instability in the cervical spine
  • Cervical degenerative disc disease at more than one level
The manufacturer has patient resources that provide the full range of indications and contraindications for the device. 

Summary

The FDA approved the use of the SECURE-C in 2012. The safety and effectiveness of the device were studied in a multi-center, randomized clinical trial that compared the SECURE-C to conventional treatment — anterior cervical discectomy and fusion (also known as cervical fusion). 

Researchers followed patients for two years after surgery. They determined the overall success of the device based on several factors, including:
  • neck pain and disability
  • complications related to the device or surgery
  • need for additional surgeries to fix, adjust or remove the device
They also measured other factors, including neck and arm pain, patient satisfaction, the time it took for patients to return to work, and the results of medical imaging done on the cervical spine.

The overall success rate of the SECURE-C after two years was 90.1 percent, compared to 71.1 percent for cervical fusion.

What Stands Out About the Device?

The SECURE-C is designed to allow up to 15 degrees of forward/backward tilting of the head and up to 10 degrees of side-to-side bending.

Approach/Insertion

The SECURE-C is implanted using an anterior approach. This approach is preferred by most surgeons for most conditions. It also results in less disruption of the muscles surrounding the spine.

Wear Testing

The company tested the SECURE-C through 10 million cycles of wear testing, with loads and movements that simulated the natural functioning of the spine.

The results show that the wear of the device is similar to other cervical disc replacement technologies on the market. No information on the life span of the device was provided by the company.

Device Material and Design

The SECURE-C consists of two endplates made of cobalt-chromium, molybdenum, and a central plastic (polyethylene) core.
The outside surfaces of the endplates have a serrated keel that enhances fixation on the bone. The surface is sprayed with titanium.

Fixation

Both endplates have a central serrated keel that fit into spaces chiseled from the bone of the adjacent vertebrae. Titanium sprayed onto the surfaces that contact the bone encourages the bone to grow onto the device.

Degrees of Freedom and Biomechanics

After two years, the SECURE-C allowed for an average of 9.7 degrees of tilting the head forward and backward.


Final Word

With so many cervical artificial disc replacement technologies on the market, you are certain to find one that works for your condition. Before making a final choice, take some time to fully review the information provided to you by your doctor. Also, talk to your doctor about any questions or concerns that you have. This will ensure a successful surgery and a faster return to your usual activities.

Updated: March 24, 2021
Disclaimer

Information provided within this article is for educational purposes and is not a substitute for medical advice. Those seeking specific medical advice should consult his or her doctor or surgeon. If you need to consult with a specialist, you may be able find a health care provider in our Specialist Finder. SpineNation does not endorse treatments, procedures, products or physicians.


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Contributors and Experts

Dr. Benjamin Bjerke is fellowship-trained in neurosurgery and orthopedic spine surgery and specializes in surgical procedures of the cervical spine as well as minimally invasive lumbar procedures.
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