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: ProDisc™-C Total Disc Replacement
PMA Applicant: Synthes Spine, Inc.
Address: 1302 Wrights Lane East, West Chester, Pennsylvania 19380
Approval Date: December 17, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070001a.pdf
What is it? The ProDisc™-C Total Disc Replacement is a device made from metal and plastic that is placed between two adjacent vertebral bodies (neck bones) to replace a diseased cervical disc. The ProDisc™-C Total Disc Replacement consists of three parts:
- Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the adjacent vertebral bodies
- A plastic (ultra-high molecular weight polyethylene or UHMWPE) inlay that fits between the two endplates
How does it work? The plastic inlay and endplates are intended to restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the plastic inlay, which can allow movement at the level where it is implanted.
When is it used? The ProDisc™-C Total Disc Replacement is intended to be used in skeletally mature patients (people who have stopped growing) for reconstruction of the disc from C3-C7 following removal of the disc at one level for intractable symptomatic cervical disc disease (SCDD), a condition that results from a diseased or bulging disc.
What will it accomplish? The device is intended to stabilize the operated spinal level. Unlike a fusion procedure, the ProDisc™-C Total Disc Replacement 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 ProDisc™-C Total Disc Replacement should not be implanted in patients with an active infection, allergy to any of the device materials, osteoporosis, marked cervical instability, severe spondylosis, clinically compromised vertebral bodies at the level to be treated, and SCDD at more than one level.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p070001