M6-L Artificial Lumbar Disc – International Only

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

Product Highlights

The M6-L disc is the only artificial lumbar disc that mimics the anatomic structure of a natural disc by incorporating a shock-absorbing nucleus and fiber annulus in its design. Like a natural disc, the M6-L disc is designed to allow for shock absorption at the implanted level and provides a controlled range of motion at the treated level. This “natural” motion is intended to provide you with the freedom to move your back naturally.

Patient Education Websites

https://www.m6disc.global/

Indications

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. 5 EN

Contraindications

The M6-L should not be implanted in patients with the following conditions:

  • Be >75 years of age, or < 18 years of age
  • Osteopenia or osteoporosis defined as a bone mineral density with T-score ≤-1.5 as determined by spine DXA if male ≥60 years of age or female ≥50 years of age
  • Have an active systemic infection or infection at the operative site
  • Have sustained an osteoporotic fracture of the spine, hip or wrist
  • Have received medications (e.g. methotrexate, alendronate) that interfere with bone and mineral metabolism within 2 weeks of the planned date of the index surgery
  • Have a history of endocrine or metabolic disorders (e.g., Paget’s disease) known to affect bone and mineral metabolism
  • Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis
  • Prior intra-abdominal or retroperitoneal surgery that would make the approach prohibitively dangerous
  • Prior anterior surgery at the same level
  • Spinal metastases
  • Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals.
  • Have uncontrolled insulin dependent type 1 or type 2 diabetes
  • Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
  • Bony lumbar stenosis
  • Isolated radicular compression syndromes, especially due to disc herniation
  • Pars defect
  • Increased segmental instability
  • Spinal deformities, spondylolisthesis above 3mm at the involved level(s)
  • Radiological confirmation of severe facet joint disease or degeneration

Instructions For Use