DePuy Orthopaedics Ceramax System - P070026
FDA Gov. Website - Approved Devices original FDA Notice
Original FDA Approval announcement
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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Ceramax Ceramic Total Hip
System
PMA Applicant: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Drive, P.O. Box 988, Warsaw,
Indiana 46581-0988
Approval Date: December 23, 2010
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070026a.pdf1
What is it? The Ceramax 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 Ceramax Ceramic Hip System consists of:
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A metal hip stem that a doctor places into a hole drilled in the end of the thigh (hip) bone (femur).
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A Biolox delta ceramic, ball-shaped part (femoral head) that attaches to the hip stem;
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A metal, socket-shaped part (acetabular shell) implanted into the pelvis that the femoral head fits into.
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A Biolox delta 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 Ceramax Ceramic Hip 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 Ceramax Ceramic Hip System is to relieve pain and allow for increased function in the hip.
When should it not be used? The Ceramax Ceramic Hip System should not be used in patients in the following situations:
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Active or recent infections that may spread to other areas of the body (such as an inflammation of bone and bone marrow, usually caused by an bacterial infection, an infection [producing pus] of the hip joint, an open or exposed infection, urinary tract infection, or dental infection).
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Inadequate bone stock that may not support hip implant components (a test such as a Bone Density Scan (DXA) 2may be needed to determine the level of bone loss).
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Rapid spreading of a disease, seen on x-rays as joint damage or loss of bone.
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Skeletally immature patients ( patients whose bones have not stopped growing).
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Muscle and/or tissue loss or deformity in the upper femur such as a birth defect affecting the leg bones.
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Cases where muscles may be too weak to work properly, nerve or vascular disease that may prevent the artificial hip joint device from remaining stable.
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Any nerve or muscle disease that may have a negative effect on walking or weight bearing.
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Inflammatory degenerative joint disease (such as rheumatoid arthritis).
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Joint instability.
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The presence of any known tumor-causing or cancer-spreading disease.
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A suppressed immune system due to diseases such as AIDS or receiving high doses of corticosteroids.
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Known allergies to metal or metal hypersensitivity.
