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New Device Approval

CHARITÉ™ Artificial Disc - P040006

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: CHARITÉ™ Artificial Disc
Applicant: DePuy Spine, Inc.
Address: DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767
Approval Date: October 26, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040006a.pdf

What is it? The CHARITÉ™ Artificial Disc 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 with degeneration of the disc confirmed by patient history and radiographic studies. The CHARITÉ™ Artificial Disc is implanted to replace a diseased or damaged intervertebral disc during a surgical procedure called spinal arthroplasty.

How does it work? The CHARITÉ™ Artificial Disc 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) core that fits between the two endplates

The plastic core and endplates help restore the natural distance between the two vertebrae (disc height). The endplates can slide over the domed parts of the core, which can allow movement at the level where it is implanted.

When is it used? The CHARITÉ™ Artificial Disc is indicated for spinal arthroplasty in patients who:

• are skeletally mature
• have degenerative disc disease (DDD) at one level in the lumbar spine (from L4-S1)
• have no more than 3mm of 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 CHARITÉ™ Artificial Disc is used to replace a damaged intervertebral disc. The device may restore disc height, reduce pain, and allow movement at the level where it is implanted.

When should it not be used? The CHARITÉ™ Artificial Disc should not be used in patients who have any of the following:

• Active systemic infection or infection localized to the site of implantation
• Osteoporosis
• Osteopenia
• Bony lumbar stenosis
• Allergy or sensitivity to implant materials
• Isolated radicular compression syndromes, especially due to disc herniation
• Pars defect

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040006.html

• Other:
  FDA Talk Paper:
  http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01320.html

  Information on spinal diseases:
  http://www.nlm.nih.gov/medlineplus/spinaldiseases.html

Updated November 17, 2004

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