This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: M6-C™ Artificial Cervical Disc
PMA Applicant: Spinal Kinetics LLC
Address: 501 Mercury Drive, Sunnyvale, CA 94085
Approval Date: February 6, 2019
Approval Letter: Approval Order
What is it? The M6-C™ Artificial Cervical Disc is an implant (device) that replaces the function of a damaged or diseased disc of the neck in the spine (C3-C7). The M6-C™ contains a series of polymer (ultra-high molecular weight polyethylene) fibers wound in a specific pattern. The fiber is wound around a polymer (polycarbonate urethane) core and through the slots in two titanium alloy inner endplates. The two titanium alloy inner endplates are welded to two titanium alloy outer endplates. The endplates attach to the patient's spinal bone and the implant is designed to maintain the natural movement of the spine.
How does it work? The implanted device replaces a damaged or diseased disc of the neck in the spine. It is intended to relieve pain and allow motion in all directions (like a pivoting joint) at the operated spinal level.
When is it used? The M6-C™ Artificial Cervical Disc is used for people who have fully formed and fully grown bones (are skeletally mature) to replace a disc in the neck (from C3-C7) following the removal of the disc for conditions that result from a diseased or bulging disc for one disc.
What will it accomplish? The device is designed to help stabilize the spine. Unlike a fusion procedure, the M6-C™ Artificial Cervical Disc is designed to allow motion at the operated spinal level, although not all patients will achieve motion after treatment. The device may lessen neck and/or arm pain and it may help patients return to their normal activities. In the clinical study of 152 patients, there was an 86.8% overall success rate at 24 months.
Some of the most common problems experienced by study patients were difficulty swallowing, neck and/or arm pain, or neurological adverse events such as numbness or tingling in the upper extremities.
When should it not be used? The M6-C™ Artificial Cervical Disc should not be used in patients with:
- An unnatural shape (deformity) of the neck
- Advanced abnormal changes at the proposed surgery level
- Advanced degeneration to the joints on the back of the spine
- An active systemic (whole body) infection or infection at the surgery site
- History of osteoporosis
- A known allergy to titanium, stainless steel, polyurethane, polyethylene or ethylene oxide residuals
Additional information (including warnings, precautions, and adverse events):