FDA Approves Trilogy AB Acetabular System
The FDA’s Center for Devices and Radiological Health (CDRH) has completed its review of Zimmer’s premarket approval application for the Trilogy AB Acetabular System. The product is approved for sales (pdf). Its manufacturer has agreed to perform a 10 year post-approval study with 250 patients to track long term safety and effectiveness. The Trilogy AB Acetabular System is indicated for use in either cemented or noncemented hip arthroplasty and aims to address the issue of wear and friction debris following total hip replacements. It is not appropriate in several cases including active joint infections and obesity.
According to Zimmer, its Trilogy Acetabular System is the world’s largest selling family of acetabular products with a reported 2005 revenue for Trilogy Acetabular Shells and associated liners was approximately $150 million. The product has been available for sales outside the U.S. for the last five years.
June 28, 2006 Related topics: Product Approval & Certification, Orthopedic