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: Ceramic TRANSCEND® Articulation Hip System
Manufacturer: Wright Medical Technology, Inc.
Address: 5677 Airline Road, Arlington, TN 38002
Approval Date: February 3, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p010001a.pdf
What is it? The Ceramic TRANSCEND® Articulation Hip System is a “ceramic-on-ceramic” total hip replacement system, surgically implanted to completely replace a diseased hip joint. For a picture of a hip implant go to:
How does it work? A stiff rod, called the femoral stem, is first inserted into the shaft of the thigh bone (the femur), and the ball-shaped part of the artificial hip joint, called the femoral head, is attached to this. The cup-shaped part of the joint, called the acetabular cup, is implanted into the cup-shaped space on the outer side of the hip. The femoral head and the acetabular cup fit together and are free to move against each other.
When is it used? The Ceramic TRANSCEND® Articulation Hip System is for patients who need replacement of a hip joint that is painful or cannot function because of arthritis, injury, or dislocation.
What will it accomplish? The Ceramic TRANSCEND® Articulation Hip System relieves pain and allows for increase function in the hip.
When should it not be used? The Ceramic TRANSCEND® Articulation Hip System should not be used in patients who have:
- infection in the joint;
- weak bones or other bone problems;
- bones that are still growing;
- nerve problems or muscle problems
- hepatitis or HIV infection;
- problems with obesity where obesity is defined as three times normal body weight;
- tested positive for pregnancy;
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010001