Frequently Asked Questions
Explore some of the most frequently asked questions to ask a surgeon before cervical spinal surgery.
FAQs for the M6-C Artificial Cervical Disc
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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. If you would like to talk to a doctor in the U.S. to see if the M6-C disc is right for you, we can help you find a certified M6-C disc surgeon here. Check back often as we add additional surgeons trained to implant the M6-C artificial cervical disc.
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The M6-C is currently approved in the U.S. for single-level disc replacement procedures only.
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If you have questions or concerns with the device you should reach out to your health care provider for immediate assistance. You can also report any concerns via our M6-C Customer Service:
U.S. Customer Service: 1-888-298-5700 or OSI-CustomerService@orthofix.com
International Customer Service: +1 408-636-2515 or CustomerService@spinalkinetics.com
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At this time there are no studies being conducted in the U.S. on the M6-C disc. Please visit Orthofix.com as future studies will be announced there.
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The M6-C artificial cervical disc is indicated for reconstruction of the disc following single-level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 – C7. Degenerative cervical radiculopathy is defined as arm pain and/or a neurological deficit (numbness, weakness, deep tendon reflexes changes) with or without neck pain due to disc herniation and/or osteophyte formation and confirmed by radiographic imaging (CT, MRI, X-rays). The M6-C artificial cervical disc is implanted via an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or exhibit progressive neurological symptoms which could lead to permanent impairment prior to implantation of the M6-C artificial cervical disc.
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The metallic components of the device are manufactured from medical grade titanium alloy – Titanium 6Al-4V (ASTM F1472 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications) and commercially pure titanium (ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coating of Surgical Implants).
Further information regarding ASTM Standards can be found online at: https://www.astm.org/industry/health-care-and-medical-devices-standards.html. These standards describe the constituent element and alloy composition allowed in the metal. These standards may be purchased online. Orthofix cannot provide copies of the standards since they are copyrighted material. The remaining components are derived from medical grade polymers. The core and sheath are made of polycarbonate urethane (PCU), and the fiber surrounding the core is made of ultra-high molecular weight polyethylene (UHMWPE). These polymer materials are proprietary to third-party suppliers, and are not subject to a material composition standard (such as an ASTM standard).
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Please consult your physician to discuss any concerns that you may have regarding metal allergies. The metallic components of the M6-C artificial disc are manufactured from medical grade titanium alloy – Titanium 6Al-4V (ASTM F1472 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications) and commercially pure titanium (ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coating of Surgical Implants).
Further information regarding ASTM Standards can be found online at: https://www.astm.org/industry/health-care-and-medical-devices-standards.html. These standards describe the constituent element and alloy composition allowed in the metal. While the titanium material used to make the disc is biocompatible and has been used in other medical implants for many years, there is no guarantee that anyone susceptible to metal allergies will not experience a problem.
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The M6-C disc is a one-piece construct. The M6-C disc is designed to replicate the anatomic structure of a natural disc by incorporating an artificial nucleus and annulus into its design. The artificial nucleus of the M6-C disc is composed of a compressible polycarbonate urethane material. The artificial annulus is a polyethylene fiber structure that is wound in multiple redundant layers around the artificial nucleus and through titanium endplates. Together, the artificial nucleus and annulus are designed to provide motion characteristics similar to that of a natural disc. The M6-C disc also has a polymer sheath surrounding the artificial nucleus and artificial annulus designed to minimize any tissue in-growth as well as the migration of wear debris. The titanium plates have serrated fins for anchoring the disc to the bones of neighboring vertebrae. These titanium plates are coated with a titanium plasma spray that is intended to promote bone growth onto the plates, providing long-term stability of the M6-C artificial cervical disc in the disc space.
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Because the M6-C disc is a one-piece construct, the individual parts that make up each disc cannot be replaced. As with many long-term implanted medical devices, mechanical failures may occur. The cause of mechanical failures can be attributed to a variety of causes to include infection, surgical technique, disc positioning, and/or patient selection. The overall rate of all M6-C product events reported to Orthofix is low. Your surgeon can best explain his/her results and experience with the M6-C disc and if he/she has observed any mechanical failures in any of their patients.
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The M6-C disc is a long-term implant device. The disc, once implanted, is anticipated to last the lifetime of the individual.
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After implantation with the M6-C disc, your postoperative limitations regarding your activities of daily living are highly individualized. Many individuals return to their “normal” activities between two and six weeks, depending on their doctor’s guidelines. If your activities involve impact sports, such activities may be limited after implantation of an artificial disc. Consult your surgeon on what activity limitations may be expected after receiving an artificial disc.
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As with any surgery, you should expect some discomfort. Most patients are discharged either the same day or the day after surgery. Your surgeon will give you specific guidelines for activities and follow-up requirements before you leave the hospital with your device. In order to obtain the most optimal clinical outcome, it is important to adhere to these guidelines for successful treatment. Based on your doctor’s recommendations, you will need to take it easy for the first two weeks before slowly returning to normal activities such as driving and working. Avoid activities that involve repeated bending, twisting and lifting. Your surgeon will schedule follow-up exams after your procedure to assess your recovery, but most people typically return to normal activities between two and six weeks.
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MRI Safety Information:
MR Conditional
Non-clinical testing demonstrated that the M6-C disc is MR Conditional. A patient with this device can be scanned safely in an MR system under the following conditions:
- Static magnetic field of 1.5-Tesla or 3-Tesla, only
- Maximum spatial gradient magnetic field of 4,000-Gauss/cm (40-T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode.
Under the scan conditions defined, the M6-C disc is expected to produce a maximum temperature rise of 2.2°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by the M6-C disc extends approximately 10-mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.
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CT, or CAT scans, are special X-ray tests that produce cross-sectional images of the body using X-rays and a computer. There are no contraindications to receiving a CT or X-ray after having the M6-C disc implanted.
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With every medical device and associated procedure there are potential risks and adverse events. For full information on instructions for use, contraindications, warnings, precautions, adverse reactions information, and sterilization, click here to download the IFU.
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The M6-C disc has been subjected to rigorous testing necessary to allow the device to be approved by the FDA for sale in the U.S., as well as by other international regulatory agencies in the various markets where it is distributed. For more information visit fda.gov.
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Please consult your physician for any questions regarding artificial cervical disc replacement. For questions regarding the M6-C disc, please contact Orthofix Customer Service at:
U.S. Customer Service: 1-888-298-5700 or OSI-CustomerService@orthofix.com