Frequently Asked Questions About the M6 Artificial Disc

1. How many M6 artificial discs have been implanted to date?

As of the most recent update to these FAQs, there have been approximately 50,000 M6 artificial cervical and lumbar discs implanted throughout the world. Two thirds of this total is attributed to the M6-C Artificial Cervical Disc, and the remaining to the M6-L Artificial Lumbar Disc.

The M6-C was first implanted in 2005, and the M6-L in 2009.

2. When will the M6-C Artificial Cervical Disc be approved in the US?

The M6-C Artificial Cervical Disc is not FDA approved for sale in the US at this time.

Spinal Kinetics is pursuing FDA approval of the M6-C for use in the US. At this time, there is no definitive date or additional information regarding when this approval could occur.

We recommend you occasionally check the Spinal Kinetics website (www.spinalkinetics.com) for any updates on the approval status of M6-C in the US. Any future US FDA approval will be posted on our website.

3. When will the M6-L Artificial Lumbar Disc be approved in the US?

The M6-L Artificial Lumbar disc is not FDA approved for sale in the US at this time.

Currently there are no plans by Spinal Kinetics to initiate an FDA submission or US clinical trial for approval of the M6-L in the US.

4. What if I want to go outside the US to get the M6-C Artificial Cervical Disc or the M6-L Artificial Lumbar Disc?

If you have interest in learning more about M6-C or M6-L treatment options outside the US, it is quite likely that an internet search will reveal various international surgeons who have experience using M6-C or M6-L discs. Some of the more popular Spine patient websites/blogs may discuss such patient experiences including costs and logistics with different surgeons.

Spinal Kinetics does not sponsor, promote, or otherwise have any involvement in the activities associated with patients who travel abroad to seek medical or surgical treatment. Unfortunately, we are unable to provide information on which surgeons may accept international patients, nor the logistics of such arrangements, including insurance coverage limits or other options for patients.

Spinal Kinetics does not provide lists or names of our surgeon customers, as this information is considered confidential to our business. We are not able to recommend to potential patients any specific surgeon who uses our product. Please contact the surgeon’s office directly and ask him/her these very important questions.

5. Are there any studies I can be involved in for the M6-C / M6-L Artificial Disc?

At this time there are no studies being conducted in the US on either the M6-C Artificial Cervical Disc or the M6-L Artificial Lumbar Disc.

You may check the Spinal Kinetics website (www.spinalkinetics.com) occasionally for any update on new studies that may occur for either disc. Information about any future studies will be prominently posted on our website.

6. What are the indications for the M6-C / M6-L Artificial Disc?

Neither the M6-C Artificial Cervical Disc nor the M6-L Artificial Lumbar Disc is approved in the US at this time. Therefore, there are no approved indications for use in the US.

Indications for use as stated in our Outside the US (European Union) labelling are as follows:

M6-C Artificial Cervical Disc Indications for Use:
The M6 Artificial Cervical Disc System is intended for use in skeletally mature patients undergoing primary surgery for treatment of symptomatic disc diseases of the cervical spine at any one level or multiple levels between C3 through C7, who have not responded to non-operative conservative management.* The disease state is demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height.

  • The non-operative conservative management requirement may be waived in the cases of myelopathy requiring immediate treatment and/or cervical radiculopathy with worsening neurological functions (i.e. motor weakness).

M6-L Artificial Lumbar Disc Indications for Use:
The Spinal Kinetics M6-L Artificial Lumbar Disc System is intended for use in skeletally mature patients undergoing primary surgery for treatment of symptomatic degenerative disc disease (DDD) 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 DDD patient may also have up to 3mm of spondylolisthesis at the involved level. The disease state is demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height.

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.

7. In which countries is the M6-C/M6-L Artificial Disc approved for use?

In 2006, the M6-C 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-C and M6-L are approved for use in the following countries:


M6-C Artificial Cervical Disc
European Union Countries
Switzerland
Australia
New Zealand
Russia
South Africa
Brazil
United Arab Emirates
Mexico
Turkey
Canada

M6-L Artificial Lumbar Disc
European Union Countries
Switzerland
Australia
New Zealand
Russia
South Africa
Brazil
United Arab Emirates


8. Who distributes the M6 in the various approved countries outside the US?

The M6 artificial disc technology is distributed through independent spine sales organizations throughout the various countries listed above. To find a Spinal Kinetics distribution partner for a specific country, click on the following link: http://www.spinalkinetics.com/en/company/international-distributor-list/

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
Fax: +49 7333 9259987
info-germany@spinalkinetics.com

9. What is the M6-C / M6-L Artificial Disc made out of?

The M6-C Artificial Cervical Disc and the M6-L Artificial Lumbar Disc are made of the same materials.

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. Spinal Kinetics 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).

10. Can I have the M6 implanted in me if I have metal allergies?

The metallic components of the M6 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. Consult your physician to discuss any concerns that you may have regarding metal allergies.

11. Is the M6-C / M6-L Artificial Disc a one-piece device?

The M6-C Artificial Cervical Disc and M6-L Artificial Lumbar Disc are both one-piece constructs. The M6 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 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 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.

12. Can M6-C / M6-L Artificial Disc parts be replaced if they wear out?

Because both the M6-C Artificial Cervical Disc and the M6-L Artificial Lumbar Disc are one-piece constructs, the individual parts that make up each disc cannot be replaced.

As with many long-term implanted medical devices, mechanical failures have occurred. The cause of mechanical failures can be attributed to a variety of causes to include surgical technique, disc positioning, and/or patient selection. The overall rate of all M6 product events reported to Spinal Kinetics is low. Your surgeon can best explain his/her results and experience with the M6 and if he/she has observed any mechanical failures in any of their patients.
The M6-C disc was commercialized in 2006 and the M6-L disc was commercialized in 2009.

13. What is the expected lifetime of the M6-C / M6-L Artificial Disc once implanted?

The M6-C disc and the M6-L disc are long-term implant devices. The disc, once implanted, is anticipated to last the lifetime of the individual.

14. What limit(s) on my physical activity will I have after having an M6-C / M6-L Artificial Disc implanted (i.e. contact sports, weight lifting, etc.)?

After implantation with either the M6-C Artificial Cervical Disc or the M6-L Artificial Lumbar Disc, your postoperative limitations regarding your activities of daily living are highly individualized. Many individuals return to their “normal” activities. If your activities involve impact sports or 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.

15. Can the M6-C / M6-L Artificial Disc be implanted at more than one level?

Yes, please see answer above regarding each disc’s Indications for Use.

16. Can I have an MRI after getting the M6-C / M6-L Artificial Disc?

Yes, both the M6-C Artificial Cervical Disc and the M6-L Artificial Lumbar Disc are MR Conditional.

MRI Safety Information:

MR
MR Conditional

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

Non-clinical testing demonstrated that the M6-L Artificial Lumbar 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 Artificial Lumbar Disc is expected to produce a maximum temperature rise of 2.6°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by the M6-L Artificial Lumbar Disc extends approximately 10-mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

17. Can I have a CT after getting the M6-C / M6-L Artificial Disc?

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 other x-rays after having either the M6-C or M6-L Artificial Disc implanted.

18. Who should I contact at Spinal Kinetics if I am interested in distributing the M6 in the US or other international countries?

Spinal Kinetics distributes the M6 through top independent distributor organizations experienced in customer service, clinical knowledge and case support. Email M6distribution@spinalkinetics.com to inquire and learn more about potential distribution partnering opportunities with Spinal Kinetics for both US and OUS territories.

Distribution in the US will not occur until FDA approval is obtained.

19. What are the known complications with the M6?

With every medical device and associated procedure there are potential risks and adverse events. The following are the known events that could occur with the M6 Cervical and/or Lumbar Artificial disc, as well as risks associated with general and spine surgery.

M6-C Cervical Disc Potential Risks and Adverse Events:

  • Adverse/allergic reaction to implant materials
  • M6 cervical disc migration in the anterior-posterior direction
  • M6 cervical disc subsidence requiring subsequent surgical intervention
  • Placement difficulties requiring acute implant removal
  • Excessive facet loading
  • Kyphosis or hyper-extension
  • Loss of flexibility
  • Asymmetric range of motion
  • Spondylotic bridging
  • Vertebral body fracture
  • Infection
  • Spinal cord damage
  • Neurologic damage or failure to relieve symptoms
  • Implant failure
    • M6 cervical disc wear, fatigue or fracture
    • M6 cervical disc instability leading to unstable movement of the spine
    • Separation of M6 cervical disc components
    • Excessive M6 cervical disc height loss requiring subsequent surgical intervention
    • Wear debris
    • Material degradation

M6-L Lumbar Disc Potential Risks and Adverse Events

  • Adverse/allergic reaction to implant materials
  • M6-L migration in the anterior-posterior direction
  • M6-L subsidence requiring subsequent surgical intervention
  • Placement difficulties requiring acute implant removal
  • Excessive facet loading
  • Kyphosis or hyper-extension
  • Loss of flexibility
  • Asymmetric range of motion
  • Spondylotic bridging
  • Vertebral body fracture
  • Infection
  • Spinal cord damage
  • Neurologic damage or failure to relieve symptoms
  • Implant failure
    • M6-L wear, fatigue or fracture
    • M6-L instability leading to unstable movement of the spine
    • Separation of M6-L components
    • Excessive M6-L height loss requiring subsequent surgical intervention
    • Wear debris
    • Material degradation

Risks associated with general and spine surgery include:

  • Excessive bleeding
  • Anesthesia reaction
  • Respiratory disorders
  • Heart attack
  • Nerve or spinal cord damage leading to sensory loss
  • Pneumonia
  • Blood mass/clot
  • Side effects from medicine used during and after surgery
  • Scarring of the spinal canal sheath
  • Bruising
  • Damage to blood vessels near spine
  • Opening of the wound
  • Loss of fluid surrounding the spinal cord
  • Stroke
  • Superficial or deep wound infection
  • Accumulation of fluid within the incision
  • Additional surgery
  • Incorrect treatment level
  • Ongoing pain
  • Spinal fractures

20. Has the M6 been tested for durability?

Both the M6-C Artificial Cervical Disc and the M6-L Artificial Lumbar Disc have been subjected to rigorous testing necessary to allow the device to be approved for sale in the various markets where it is distributed. The testing is proprietary to the company, and it is unpublished data that is shared with regulatory authorities and surgeons as appropriate. If you have specific questions regarding this testing, your surgeon should be able to answer your questions, or he/she can contact Spinal Kinetics for any specific requests.

21. What if I have further questions?

We encourage you to email your questions to inquiries@spinalkinetics.com. Answers to emails are usually provided at a much faster rate than responses to messages left in the Spinal Kinetics general mailbox.