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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: PRODISC®-L Total Disc Replacement
PMA Applicant: Synthes Spine, Inc.
Address: 1302 Wright Lane EastWest Chester, PA 19380
Approval Date: August 14, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050010a.pdf
What is it? The PRODISC®-L Total Disc Replacement is an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD). DDD is defined as discogenic back pain (pain resulting from a degenerated intervertebral disc) with degeneration of the disc confirmed by patient history and radiographic studies. The PRODISC®-L Total Disc Replacement is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.
How does it work? The PRODISC®-L Total Disc Replacement consists of three parts:
- Two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae)
- A plastic (ultra-high molecular weight polyethylene, or UHMWPE) inlay that fits between the two endplates
The plastic inlay and endplates help restore the natural distance between the two vertebrae (disc height). The top (superior) endplate can slide over the domed part of the inlay, which can allow movement at the level where it is implanted.
When is it used? The PRODISC®-L Total Disc Replacement is indicated for spinal arthroplasty in patients who:
- are skeletally mature
- have degenerative disc disease (DDD) at one level in the lumbar spine (from L3-S1)
- have no more than Grade 1 spondylolisthesis at the involved level
- have had no relief from pain after at least six months of non-surgical treatment
What will it accomplish? The PRODISC®-L Total Disc Replacement is used to replace a damaged intervertebral disc. The device may restore disc height, may reduce pain, and may allow movement at the level where it is implanted.
When should it not be used? The PRODISC®-L Total Disc Replacement should not be used in patients who have any of the following:
- Active systemic infection or infection localized to the site of implantation
- Osteopenia or osteoporosis defined as DEXA bone density measured T-score < -1.0
- Bony lumbar spinal stenosis
- Allergy or sensitivity to implant materials (cobalt, chromium, molybdenum, polyethylene, titanium)
- Isolated radicular compression syndromes, especially due to disc herniation
- Pars defect
- Involved vertebral endplate dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions
- Clinically compromised vertebral bodies at affected level due to current or past trauma
- Lytic spondylolisthesis or degenerative spondylolisthesis of Grade > 1
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050010