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: DePuy Ceramax Ceramic Total Hip System
PMA Applicant: DePuy Orthopaedics, Inc.
Address: P.O. Box 988, 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988
Approval Date: April 2, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf7/p070026s004a.pdf
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:
- A metal hip stem that a doctor places into a hole drilled in the end of the thigh (hip) bone (femur).
- A Biolox delta ceramic, ball-shaped part (femoral head) that attaches to the hip stem.
- A metal, socket-shaped part (acetabular shell) implanted into the pelvis that the ceramic insert fits into.
- A Biolox delta ceramic insert that fits into the acetabular shell.
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 relieves pain and allows 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:
- Skeletally immature patients (tibial and femoral epiphyses not closed);
- Evidence of active infections that may spread to other areas of the body including osteomyelitis, pyogenic infection of the hip joint, overt infection, and urinary tract infection;
- The presence of any known tumor-causing (neoplastic) or cancer that has spread (metastatic disease);
- Significant neurologic or musculoskeletal disorders or diseases that may adversely affect walking (gait), weight bearing or postoperative recovery including muscular dystrophy and multiple sclerosis;
- Presence of highly communicable disease(s) that may limit follow-up visits including immuno-compromised conditions, hepatitis, and active tuberculosis;
- Any condition that may interfere with postoperative recovery including Paget’s disease and Charcot’s disease;
- Inadequate bone stock to support the device including severe osteopenia or osteoporosis;
- Poor skin coverage around the hip joint;
- Known allergies to the implant materials;
- Marked muscle and/or tissue loss (atrophy) or deformity in the upper femur such as a birth defect affecting the leg bones;
- Inflammatory degenerative joint disease, such as rheumatoid arthritis;
- Joint instability
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.