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: Stelkast Supass™ Acetabular System
Manufacturer: Stelkast Company
Address: 200 Hidden Valley Road, McMurray, Pennsylvania 15317
Approval Date: May 12, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040051a.pdf
What is it? The Stelkast Surpass™ Acetabular System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint.
How does it work? The Stelkast Surpass™ Acetabular 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 top end of the hip stem;
- A ceramic insert that the femoral head fits into; and,
- A metal, socket shaped part (acetabular shell) implanted into the pelvis that the ceramic insert fits into.
The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move. The metal hip stem and metal acetabular shell are intended for cementless use and are held in place by a press-fit into the surrounding bone. Porous surface coatings on some metal components help to aid long-term fixation by allowing for tissue ingrowth.
When is it used? The Stelkast Surpass ™ 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 Stelkast Surpass™ Acetabular System is intended to relieve pain and allow for increased function in the hip.
When should it not be used? The Stelkast Surpass ™ Acetabular System should not be used in patients with:
- Insufficient quantity or quality of bone to allow appropriate insertion and fixation of the prosthesis;
- Insufficient soft tissue integrity to provide adequate stability;
- Muscle laxity or inadequate soft tissue for proper function and healing;
- Neuromuscular disorders that do not allow control of the affected joint;
- Active joint infections or chronic systemic infections;
- Obesity; or,
- 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=p040051