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M6-C™ Artificial Cervical Disc

Description

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​​​​PRODUCT DESCRIPTION

The M6-C™ artificial cervical disc technology provides an alternative to spinal fusion and is designed to restore natural and physiologic motion. Preserving motion with the M6-C disc provides an opportunity to restore biomechanical function at the treated level after native disc removal, as well as the possibility to reduce subsequent degeneration of adjacent segments. With its innovative single piece design for ease of implantation and ability to replicate a natural disc's motion, the M6-C artificial cervical disc is the natural choice. ​ Visit www.M6disc.com​ for more information.

Features​

Sheath:
  • Viscoelastic polymer (PCU) designed to minimize tissue in-growth and debris migration
Fixation:
  • 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

Artificial Nucleus: 
  • Viscoelastic polymer (PCU) designed to stimulate native nucleus structure
  • In combination with the artificial annulus, allows physiologic axial coompression
  • Retained between endplates by fiber annulus matrix
Artificial Annulus: 
  • 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


Indication

INDICATIONS

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.​

Contraindications​

The M6-C™ Artificial Cervical Disc should not be implanted in patients with the following conditions:​

  • Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels

  • Symptomatic facet arthrosis defined as pain in the neck that is worse when in extension and/or rotation and/or stiffness or the inability to move part of the neck attributable to the facets as confirmed by imaging (x-ray, CT, MRI, bone scan)

  • Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, excessive translation or kyphotic deformity > 11° on neutral x-rays

  • Active systemic infection or infection at the operative site

  • Osteoporosis defined as DEXA bone mineral density T-score ≤ -2.5

  • Known allergy to titanium stainless steel, polyurethane, polyethylene, or ethylene oxide residuals​

Clinical References

Resources