Evidence from the U.S. IDE clinical trial continues to demonstrate the safety and efficacy of the M6-C artificial disc. The M6-C disc is the only FDA-approved artificial cervical disc designed to mimic the natural motion of a native cervical disc with six degrees of motion.
The Neck Disability Index (NDI) is a validated, 10-item questionnaire that measures a patient's self-reported neck pain related disability.
At 5 years post-op, M6-C subjects had a mean NDI score of 8.0 - significantly better than the mean of 18.0 observed in the ADCDF control group.
NDI Score
The FDA categorizes the subsequent surgical interventions as Revision, Removal, Supplemental Fixation, and Re-Operation.
At the 5-year endpoint, the M6-C disc continues to demonstrate one of the Lowest Subsequent Surgical Intervention rates when compared to other FDA-approved artificial cervical discs.
SSI Rate
The Visual Analog Score (VAS) is a validated, subjective measure for accute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
At 5 years, post-op subjects had a mean Shoulder/Arm pain VAS score of 0.5, which was significantly better than the mean of 2.1 observed in the ACDF control group.
VAS Score
M6-C Rankings
ACDF Control Group
VAS
SSI
NDI
0.5
3.1%
8.0
2.1
0%
18.0
u.s. ide 5-year results
Hear from patients living with the M6-C Artificial Cervical Disc
70,000+ devices implanted in over 20+ countries.
in over 20+ countries
The M6-C is the #1 implanted artificial cervical disc in Australia, and most-studied cervical disc in the Australian Orthopedic Association National Joint Replacement Registry.
35,000+
5 Years
The number of M6-C devices implanted worldwide has positioned M6-C disc as a global leader in the cervical arthroplasty segment.
7 Years
25,000+
10 Years
The number of M6-C discs that have been implanted for more than
12,000+
Titanium alloy endplates with low profile tri-fin design provides acute fixation to the superior and inferior vertebral bodies.
Titanium Plasma Spray (TPS) coating intended to promote bone growth, providing long-term stability.
FIXATION
Viscoelastic polymer (PCU) designed to simulate native nucleus structure.
In combination with the artificial annulus, allows physiologic axial compression.
Retained between endplates by fiber annulus matrix.
ARTIFICIAL NUCLEUS
Viscoelastic polymer (PCU) designed to minimize tissue in-growth and debris migration.
SHEATH
Ultra High Molecular Weight Polyethylene (UHMWPE) fiber matrix designed to simulate native annular structure.
In combination with the artificial nucleus, allows controlled motion in all planes and axes of rotation.
Robust fiber matrix with multiple fiber layers similar to native annulus.
ARTIFICIAL ANNULUS
The M6-C disc is the only FDA-approved artificial cervical disc designed to mimic the natural motion of a native cervical disc with six degrees of motion.
Click on the image of the disc below to take a look at our innovative M6-C technology.
The number of M6-C discs that have been implanted for more than
The number of M6-C discs that have been implanted for more than
The number of M6-C discs that have been implanted for more than:
5 YEARS
7 YEARS
10 YEARS
The M6-C™ disc is the only FDA-approved artificial cervical disc designed to mimic the natural motion of a native cervical disc with six degrees of motion.
VIDEO HEADLINE
SECTION 1
Long-Term Outcomes of CDR: Available IDE Data
reduction in shoulder & arm pain
The Visual Analog Score (VAS) is a validated, subjective measure for acute and chronic pain. M6-C patients experienced significant reductions in pain and significant improvements in overall disability as compared to patients who received fusion. At 5-years post-op, M6-C subjects had a mean Shoulder/Arm Pain score of 0.5 - significantly better than the mean of 2.1 observed in the ACDF control group. At 7-years post-op, the M6-C subjects had a mean Shoulder/Arm Pain score of 0.5. Therefore, the decrease in pain observed at earlier time periods is retained through 7-years post-op.
VAS
SSI
NDI
M6-C
ACDF Control Group
Low repeat surgery rates
Subsequent Surgical Interventions (SSI) represent an effective way to evaluate the long-term stability of the device at the implanted level. At the 7-year endpoint, the M6-C disc had a SSI rate of 6.9% which is comparable to other FDA-approved artificial cervical discs.*
NECK DISABILITY INDEX (NDI)
The Neck Disability Index (NDI) is a validated, 10-item questionnaire that measures a patient's self-reported neck pain related disability. At 5-years post-op, M6-C subjects had a mean NDI score of 8.0 - significantly better than the mean of 18.0 observed in the ACDF control group. At 7-years post-op, the M6-C subjects had a mean NDI score of 9.3. Therefore, the decrease in disability observed at earlier time periods is retained through 7-years post-op. Decreases in disability as measured by NDI and decreases in Neck and Arm Pain Scores that were observed at prior follow-up periods and were retained through seven-years post-op.
KOA ROTHMAN
SURFER
RANDY
FIREFIGHTER
KEVIN
RUNNER
SECTION 2
Long-Term Outcomes of M6-C CDR: One Surgeon’s Experience
results from the u.s. ide study
Real world results
Learn more about the M6-C disc from our panel of surgeon experts.
Click on an icon below for facts about the M6-C Artificial Cervical Disc
VIDEO HEADLINE
Patient focused.
Proven results.
6.9%
N/A
0.5
2.1
8.0
18.0
Recently released data from the prospective, multi-center U.S. IDE study further validates the safety and strong performance of the M6-C artificial cervical disc.
Click the icon to download the PowerPoint Presentation.
Only FDA approved and commercially available cervical disc with six degrees of motion, including backward and forward, up and down, side to side, and rotation left and right.
Only artificial disc that mimics the anatomic structure of the natural disc.
Only artificial disc that has a shock-absorbing nucleus and fiber annulus that work together to replicate the controlled range of movement and cushioning effect of natural spine.
READY TO LEARN MORE? GO TO M6DISC.COM
%
suggest a global cumulative survivorship of 99% at 10 years.
16 Years of Real World Evidence
Results of a Kaplan Meier analysis of the M6-C disc based on
m6disc.com
REAL RESULTS
U.S. IDE RESULTS
M6-C DISC DESIGN
REAL PATIENTS
M6-c disc design
real patients. real results.
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99
%
93
93% of m6-c disc patients said they would have the surgery again
*Data on file
Orthofix products or services referenced herein are trademarks or registered trademarks of Orthofix Medical Inc. and its group of companies. Any rights not expressly granted herein are reserved.
proven results.
global cumulative survivorship at 10 YEARS
40,000 discs
30,000 discs
15,000 discs
Titanium alloy endplates with low profile tri-fin design provides acute fixation to the superior and inferior vertebral bodies.
Titanium Plasma Spray (TPS) coating intended to promote bone growth, providing long-term stability.
FIXATION
Viscoelastic polymer (PCU) designed to simulate native nucleus structure.
In combination with the artificial annulus, allows physiologic axial compression.
Retained between endplates by fiber annulus matrix.
ARTIFICIAL NUCLEUS
Viscoelastic polymer (PCU) designed to minimize tissue in-growth and debris migration.
SHEATH
Ultra High Molecular Weight Polyethylene (UHMWPE) fiber matrix designed to simulate native annular structure.
In combination with the artificial nucleus, allows controlled motion in all planes and axes of rotation.
Robust fiber matrix with multiple fiber layers similar to native annulus.
ARTIFICIAL ANNULUS
OPEN THE DISC
M6-c disc design
patient focused. proven results.
CLOSE THE DISC
real patients. real results
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9
10
10
out of
The number of M6-C patients who reported improvement in neck pain
1
2
3
4
Tap on an element to learn more.
9
10
10
out
of
The number of M6-C patients who reported improvement in neck pain