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Zimmer to sell ceramic hip replacements
By Elaine Rigoli
Tampa, Fla., July 6 - Zimmer Holdings, Inc. has received approval of its Premarket Approval Application from the Food and Drug Administration to market the Trilogy AB ceramic-on-ceramic acetabular system.
In November 2005, the FDA issued an approvable letter indicating that the PMA was approvable subject to FDA inspection of the company's facilities related to the Trilogy AB system.
"We are very pleased to now be able to offer a ceramic-on-ceramic acetabular option to our customers in the United States. We have been anticipating this letter and are preparing to launch the product in the next two weeks, filling an important opening in our U.S. hip product portfolio," president, chief executive officer and chairman Ray Elliott said in a news release.
The Trilogy AB system is part of the Trilogy acetabular system, which was initially launched in 1994 and evolved from the Harris/Galante and HGP 2 acetabular cup system designs.
According to Zimmer, the Trilogy acetabular system is the world's largest-selling family of acetabular products.
The company said 2005 revenue for Trilogy acetabular shells and associated liners was about $150 million.
Based in Warsaw, Ind., Zimmer develops and markets reconstructive and spinal implants, trauma and related orthopedic surgical products.
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