New Device ApprovalDuraloc® Option Ceramic Hip System -
P040023
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.fda.gov/cdrh/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.
