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: NOVATION™ Ceramic Articulation Hip System
PMA Applicant: Exactech, Inc.
Address: 2320 N.W. 66th Court, Gainesville, Florida 32653
Approval Date: July 5, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050039a.pdf
What is it? TheNOVATION™ Ceramic Articulation Hip 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 NOVATION™ Ceramic Articulation Hip System is indicated for use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
What will it accomplish? The NOVATION™ Ceramic Articulation Hip System will reduce pain by replacing the painful arthritic hip joint, and restore its ability to move.
When should it not be used? The NOVATION™ Ceramic Articulation Hip System should not be used in patients who have any of the following:
- Active or latent infection in or around the hip joint;
- Acute or chronic systemic infections;
- Skeletally immaturity;
- Neurological or muscular conditions (e.g., prior paralysis, fusion and/or inadequate abductor strength) that could result in instability or overloading of the hip joint;
- Poor skin coverage around hip joint;
- Inadequate bone stock to allow proper insertion and fixation of the prosthesis;
- Metabolic bone disease and osteoporosis;
- Known allergies to the implant materials; and
- Obesity where obesity is defined as a Body Mass Index (BMI) greater than 35 .
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050039