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: PCM Cervical Disc System
PMA Applicant: NuVasive, Inc
Address: 7476 Lusk Boulevard, San Diego, CA 92121
Approval Date: October 26, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100012a.pdf
What is it? The PCM Cervical Disc 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 (vertebrae) to replace a diseased cervical disc that is 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 treated level as the plastic core, which is attached to the bottom endplate, moves against the top metal endplate.
When is it used? The PCM Cervical Disc is intended to be used in skeletally mature patients (people who have stopped growing) to replace a cervical disc from C3-C7 following removal of the disc for conditions that result from a diseased or bulging disc (intractable radiculopathy or myelopathy) at only one level.
What will it accomplish? The device should help stabilize the operated disc in the neck (spinal level). Unlike a fusion procedure, the PCM Cervical Disc is designed to allow motion at the operated spinal level. The effects of the diseased disc removal should include pain relief and improved function.
When should it not be used? The PCM Cervical Disc should not be implanted in patients with the following conditions:
- Acute or chronic infections, local or systemic
- Osteoporosis (defined as a DEXA bone density-measured T-Score less than or equal to -2.5) or osteopenia (defined as a DEXA bone density-measured T-Score equal or less than -1.0)
- Congenital stenosis
- Allergy or sensitivity to any of the implant materials (cobalt, chromium, molybdenum, titanium, or polyethylene)
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.