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: Mobi-C® Cervical Disc Prosthesis (two-level)
PMA Applicant: LDR Spine USA, Inc.
Address: 13785 Research Boulevard, Suite 200, Austin, Texas 78750
Approval Date: August 23, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110009a.pdf
What is it? The Mobi-C® Cervical Disc Prosthesis consists of two metal (cobalt-chrome alloy ) endplates and a plastic (ultra-high molecular weight polyethylene) insert that fits between the endplates. The device is placed between two adjacent neck bones (cervical vertebrae) to replace a diseased cervical disc at two adjacent levels that are causing arm pain and/or weakness or numbness.
How does it work? The implanted device is designed to restore the distance between the two vertebrae (disc height) and allow motion at the operated spinal levels as the plastic core moves against the metal endplates.
When is it used? The Mobi-C® Cervical Disc Prosthesis is intended for skeletally mature patients (people who have stopped growing) to replace two adjacent cervical discs in the neck (from C3-C7) following removal of the discs for conditions that result from diseased or bulging discs (radiculopathy or myelopathy ) at two adjacent spinal levels.
What will it accomplish? The two devices should help stabilize the operated spinal levels. Unlike a fusion procedure , the Mobi-C® Cervical Disc Prosthesis is designed to allow motion at the operated spinal levels. The effects of removing the diseased discs should include pain relief and improved function.
When should it not be used? You should avoid having surgery with the Mobi-C® Cervical Disc Prosthesis if you are experiencing any of the following conditions:
- An active whole body (systemic) infection, such as pneumonia.
- An infection at the surgery site, such as a skin rash or an infected cut.
- A known allergy or sensitivity to the materials in the device (cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements).
- Damaged cervical vertebrae from an accident (trauma) at the affected spinal levels.
- An unhealthy shape (deformity) of the cervical vertebrae at the affected spinal levels. Deformity could be caused by an inflammatory disease (such as ankylosing spondylitis or rheumatoid arthritis).
- A cervical spine that shows an unhealthy amount of extra movement (instability). This can be measured by X-rays taken on the patient’s side when the spine is still and bent.
- Low bone mineral density such as osteoporosis or osteopenia (defined as a DEXA bone mineral density T-score less than -1.5).
- Severe disease or degeneration in the joints on the back of the cervical vertebrae (facet joints).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.