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: Scandinavian Total Ankle Replacement System (STAR Ankle) PMA Applicant: Address:
PMA Applicant:Small Bone Innovations, Inc.
Address:1380 South Pennsylvania Avenue, Morrisville, Pennsylvania 19067
Approval Date: May 27, 2009 Approval Letter:
Approval Letter:http://www.accessdata.fda.gov/ cdrh_docs/pdf5/p050050a.pdf
What is it? The STAR Ankle is a non-constrained, total ankle replacement, surgically implanted to replace an ankle joint. The STAR Ankle is non-constrained because the bearing can be free to move in more than one plane along the tibial component.
How does it work? The STAR Ankle has three parts: a metal tibial component, a metal talar component and a plastic mobile bearing component. The upper flat surface of the plastic component slides against the flat surface of the tibial plate. The projecting cylinders of the tibial component serve to fix the device to bone at the distal tibia. The lower surface of the plastic mobile bearing component is concave, fitting against the convex upper surface of the talar component. The talar component is anchored into the resurfaced native talus.
When is it used? The STAR Ankle is intended for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.
What will it accomplish? The device is designed as an option to allow the patient to regain and/or retain some of his/her normal ankle mobility and function. Side effects may include pain, nerve injury, wound healing problems, and bone fracture.
When should it not be used? The STAR Ankle should not be used in patients with:
- Active or prior deep infection in the ankle joint or adjacent bones;
- Skeletal immaturity;
- Bone stock inadequate to support the device including;
- Severe osteoporotic or osteopenic condition or other conditions resulting in poor bone quality;
- Avascular necrosis of the talus;
- Prior surgery and/or injury that has adversely affected ankle bone quality;
- Malalignment or severe deformity of involved or adjacent anatomic structures including;
- Hindfoot or forefoot malalignment precluding plantigrade foot;
- Significant malalignment of the knee joint;
- Insufficient ligament support that cannot be repaired with soft tissue stabilization;
- Neuromuscular disease resulting in lack of normal muscle function about the affected
- Lower extremity vascular insufficiency demonstrated by Doppler arterial pressure;
- Patients who are severely overweight;
- Charcot joint or peripheral neuropathy that may lead to Charcot joint of the affected ankle;
- Prior arthrodesis at the ankle joint;
- Poor skin and soft tissue quality about the surgical site.
Additional information : Summary of Safety and Effectiveness and labeling are available online.
Other: Please see the following websites for additional information regarding ankle disabilities and total ankle replacement:
- American Orthopaedic Foot & Ankle Society: Patient Education & Resources
- American Academy of Orthopaedic Surgeons: Arthritis of the Foot and Ankle
- National Institutes of Health: Ankle Replacement