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Zimmer's Trilogy AB ceramic hip replacement system gets approvable letter from FDA
By E. Janene Geiss
Philadelphia, Dec. 14 - Zimmer Holdings, Inc. announced Wednesday that it has received an approvable letter from the Food and Drug Administration related to the Trilogy AB Ceramic-on-Ceramic Acetabular System.
The letter specifies that the Premarket Approval Application is approvable subject to an FDA inspection of the company's facilities related to the Trilogy AB System, according to a company news release.
The FDA has not informed Zimmer of the inspection schedule, officials said.
"We are excited to take another step toward offering a ceramic-on-ceramic acetabular option in the United States," said Ray Elliott, chairman, president and chief executive officer, in the release.
"The launch is dependent on FDA's schedule and the resolution of any findings in the inspections, but our hope is that we will be able to begin offering the ceramic-on-ceramic products in the U.S. in the first quarter of 2006."
The Trilogy AB system is part of the Trilogy Acetabular System, which was initially launched in 1994 and evolved from the successful Harris/Galante and HGP II Cup System designs.
The system is the world's largest selling family of acetabular products, officials said, adding 2005 revenue for Trilogy acetabular shells and associated liners is estimated at about $150 million.
The Trilogy AB femoral head and cup liner components are made of alumina ceramic and are designed to provide hard, wear-resistant articulating surfaces.
The company said it originally submitted its request for clearance to market the Trilogy AB products in December 2004.
Zimmer, based in Warsaw, Ind., is a developer, manufacturer and marketer of reconstructive and spinal implants, trauma and related orthopedic surgical products.
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