Frequently Asked Questions

In 2006, the M6-C disc received CE Mark approval for treatment of symptomatic disc diseases of cervical spine at any one or multiple levels between C3 and C7 in the European Union member countries. The CE Mark is the recognized medical device regulatory approval for countries in the EU. Other countries outside the European Union often reference the CE Mark for their regulatory approval as well as various country specific registration requirements. Currently, the M6-C disc is approved and available for use in the following countries:

• United States
• European Union Countries
• Canada
• Switzerland
• Australia
• New Zealand
• Russia
• South Africa
• Brazil

The M6-C disc was approved by the U.S. FDA in February 2019 for use in treating single-level cervical disc degeneration.

The M6-C disc is approved and available for treatment of symptomatic disc diseases of cervical spine at any one or multiple levels between C3 and C7 in the following countries (except for Australia and Canada):

• United States (single-level only)
• European Union Countries
• Canada (single level only)
• Switzerland
• Australia
• New Zealand
• Russia
• South Africa
• Brazil

The M6-C disc was approved by the U.S. FDA in February 2019 for use in treating single-level cervical disc degeneration.

The M6-C artificial disc technology is distributed through independent spine sales organizations throughout the various countries listed in the international distributors link below. To find a distribution partner for Spinal Kinetics, an Orthofix Company, for a specific country, click on the following link: https://www.m6disc.com/distributors/

Spinal Kinetics, an Orthofix Company, has a GmbH subsidiary that handles all sales and marketing activities for Germany as well as order fulfillment, customer service and logistics for the European markets:
Spinal Kinetics GmbH
Gottlieb-Daimler-Str. 43
D-89150 Laichingen
Germany
Tel: +49 7333 9259986
Fax: +49 7333 9259987
[email protected]

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:

International Customer Service: +1 408-636-2515 or [email protected]

At this time there are no studies being conducted on the M6-C disc. Please visit the Orthofix website as future studies will be announced there.

Approved indications for use, contraindications, warnings, and precautions may vary among different regions/countries where the M6-C disc is distributed. Please consult your physician to determine if you are a candidate for the M6-C artificial cervical disc.

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).

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.

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 a shock-absorbing 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 two titanium outer plates have serrated keels or fins that anchor the disc into the bone of the vertebral body. These outer plates are coated with a titanium plasma spray that promotes bone growth onto the metal plates, providing long term fixation and stability of the disc in the bone.

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.

The M6-C disc is a long-term implant device. The disc, once implanted, is anticipated to last the lifetime of the individual.

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.

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.

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.

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.

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.

The M6-C disc has been subjected to rigorous testing required by international regulatory agencies necessary to allow the device to be approved for sale in the various markets where it is distributed. If you have specific questions regarding this testing, your surgeon should be able to answer your questions, or he/she can contact Orthofix for any specific requests.

Please consult your physician for any questions regarding artificial cervical disc replacement. For questions regarding the M6-C disc, please contact Customer Service at:

International Customer Service: +1 408-636-2515 or [email protected]

The M6-L artificial lumbar disc is an innovative next-generation option for people needing spinal fusion or artificial disc replacement. This unique product is designed to mimic your lumbar disc’s natural structure and movement, including backward and forward, up and down, side to side, and rotate right and left. In addition, the M6-L disc is the only artificial lumbar disc featuring a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of the natural disc. By allowing your spine to move naturally, the M6-L disc is also designed to potentially minimize the stress to adjacent discs and vertebral structures.

To date, nearly 60,000 of the M6 discs have been implanted in patients worldwide since 2006.

The M6-L disc may be the right choice for you if the following statements are true:

• You have pain, weakness, numbness or tingling in your lower back, legs or feet
• Your doctor has diagnosed that you have lumbar disc damage through MRI, CT or X-rays.
• Your doctor may have diagnosed you with:
  • • Lumbar disc damage
    • Ruptured or herniated disc (herniated nucleus pulposus)
    • Bone spurs (osteophytes)
    • Degeneration of the spine from wear and tear
• You are 18 years or older
• You have already tried medications and physical therapy for at least six months with unsuccessful results, or you have symptoms that your condition is worsening

If these statements are true, then you may be a candidate for the M6-L disc. Talk to a doctor to discuss the benefits and risks with artificial lumbar disc replacement.

The M6-L disc is a unique product because it is designed to mimic your lumbar disc’s natural structure and movement. It is the only artificial lumbar disc featuring a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of the natural disc. By allowing your spine to move naturally, the M6-L disc is also designed to potentially minimize the stress to adjacent discs and vertebral structures.

Indications for use as stated in the European Union labeling are as follows:

The M6-L Artificial Lumbar Disc Indications for Use:

The M6-L Artificial Lumbar Disc System is intended for use in skeletally mature patients undergoing primary surgery for treatment of symptomatic degenerative disc disease of the lumbar spine at any one level or two adjacent levels between L3 through S1, who have not responded to at least 6 months of non-operative, conservative management.

The indications for use may be different in some countries where the discs are distributed. Please consult your surgeon to determine if you are a candidate for an artificial disc.

In 2006, the M6-L disc received CE Mark approval for implantation of the disc in the European Union member countries. The CE Mark is the recognized medical device regulatory approval for countries in the EU. Other countries outside the European Union often reference the CE Mark for their regulatory approval as well as various country specific registration requirements. Currently, the M6-L disc is approved and available for use in the following countries:

• European Union Countries
• Switzerland
• Australia
• New Zealand
• Russia
• South Africa
• Brazil
• United Arab Emirates

The M6 artificial disc technology is distributed through independent spine sales organizations throughout the various countries listed in the International Distributors link below. To find a Spinal Kinetics distribution partner for a specific country, click on the following link: International Distributors

Spinal Kinetics has a GmbH subsidiary that handles all sales and marketing activities for Germany as well as order fulfillment, customer service and logistics for the European markets.

Spinal Kinetics GmbH
Gottlieb-Daimler-Str. 43
D-89150 Laichingen
Germany

Tel: +49 7333 9259986
[email protected]

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 to Customer Service at:

Spinal Kinetics, an Orthofix Company
501 Mercury Drive
Sunnyvale, CA. 94085

Customer Service: +1 408‐636‐2515
[email protected]

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).

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.

The M6-L disc is a one-piece construct. The M6-L 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-L 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-L 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 outer plates have serrated fins that anchor 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-L disc in the disc space.

Because the M6-L 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-L product events reported to Orthofix is low. Your surgeon can best explain his/her results and experience with the M6-L disc and if he/she has observed any mechanical failures in any of their patients.

The M6-L disc is a long-term implant device. The disc, once implanted, is anticipated to last the lifetime of the individual.

After implantation with the M6-L 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 or other strenuous activities, 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.

As with any surgery, you should expect some discomfort. Most patients are discharged several days 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.

MRI Safety Information:

MR Conditional

Non-clinical testing demonstrated that the M6-L 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-L 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-L disc extends approximately 10-mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

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-L disc implanted.

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, and sterilization, click here to download the IFU.

No, the M6-L is not approved for use in the U.S.

Please consult your physician for any questions regarding artificial cervical disc replacement. For questions regarding the M6-L disc, please contact our customer service:

Spinal Kinetics LLC, an Orthofix Company

501 Mercury Drive
Sunnyvale, CA 94085
Customer Service: +1 408‐636‐2515

[email protected]