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: Reflection® Ceramic Acetabular System
Applicant: Smith & Nephew, Inc.
Address: Smith & Nephew, Inc.
1450 Brooks Road
Memphis , Tennessee 38116
Approval Date: December 17, 2004
Approval Letter : http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030022a.pdf
What is it? The Reflection® Ceramic Acetabular System is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased or damaged hip joint.
For a picture of a hip implant, go to: http://www.fda.gov/ForConsumers/ByAudience/ForKids/default.htm
How does it work? The system has four parts that that work together to allow the hip joint to move:
- A metal hip stem, which a doctor places into a hole drilled in the end of the thigh bone
- A ceramic, ball-shaped part (femoral head) that fastens to the metal hip stem,
- A ceramic, socket-shaped part (acetabulum) that the ball-shaped part fits in, and
- A metal shell that fastens the ceramic socket-shaped part to the hip bone.
The ceramic ball slides around in the ceramic socket, which allows this artificial hip joint to move.
When is it used? The Reflection® Ceramic Acetabular System is for patients who need a total hip replacement because of painful non-inflammatory arthritis. Examples of non-inflammatory arthritis are:
- wearing out of the joint due to time/use, (osteoarthritis),
- lack of blood flow to the bone (avascular necrosis), or
- joint damage due to injury (traumatic arthritis).
What will it accomplish? The Reflection® Ceramic Acetabular System will reduce pain by replacing the painful arthritic hip joint, and restore its ability to move.
When should it not be used? The Reflection ® Ceramic Acetabular System should not be used in patients who have any of the following:
- Insufficient quantity or quality of bone support; metabolic bone disease; osteoporosis
- Neurological or muscular conditions that would place extreme load or instability upon the hip joint;
- Active joint infections or chronic systemic infection
- Obese patients where obesity is defined as three times normal body weight
- Skeletal immaturity
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=p030022