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: Duraloc® Option Ceramic Hip System
Applicant: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr., P.O. Box 988 , Warsaw , IN 465810988
Approval Date: May 3, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040023a.pdf
What is it? The Duraloc® Option Ceramic Hip System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint.
How does it work? The Duraloc® Option Ceramic Hip System consists of:
- a metal hip stem, that a doctor places into a hole drilled in the end of the thigh bone;
- a ceramic, ball-shaped part (femoral head) that attaches to the hip stem;
- a metal, socket-shaped part (acetabular cup) implanted into the pelvis that the femoral head fits into; and
- a ceramic insert that fits into the acetabular cup.
The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move.
When is it used? The Duraloc® Option Ceramic Hip System is used in 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 Duraloc® Option Ceramic Hip System is to relieve pain and allow for increased function in the hip.
When should it not be used? The Duraloc® Option Ceramic Hip System should not be used in patients who:
- Have infection in the joint;
- Have weak bones or other bone problems;
- Have bones that have not stopped growing;
- Have nerve or muscle problems;
- Have hepatitis or HIV infection;
- Have problems with obesity where obesity is defined as three times normal body weight; or
- Have 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=p040023