Zimmer Holdings Receives Approvable Letter for Ceramic Hip Replacement

Zimmer Holdings, Inc., a leader in the orthopaedics industry, announced today that it has received an approvable letter from the United States Food and Drug Administration (FDA) related to the Trilogy AB(R) Ceramic-on-Ceramic Acetabular System. The letter specifies that the Premarket Approval Application (PMA) is approvable subject to an FDA inspection of the Company's facilities related to the Trilogy AB System. The FDA has not informed Zimmer of the inspection schedule.

"We are excited to take another step toward offering a ceramic-on-ceramic acetabular option in the United States," said Ray Elliott, Zimmer Holdings Chairman, President and CEO. "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(R) Acetabular System, which was initially launched in 1994 and evolved from the successful Harris/Galante and HGP II Cup System designs. According to Zimmer, the Trilogy system is the world's largest selling family of acetabular products. Estimated 2005 revenue for Trilogy acetabular shells and associated liners is approximately $150 million.

According to Zimmer, the Trilogy AB femoral head and cup liner components are made of alumina ceramic and are designed to provide hard, wear-resistant articulating surfaces. "We are pleased at the prospect of being able to offer the ceramic-on-ceramic option to U.S. customers who prefer Zimmer fiber-metal backed cups and our acetabular instruments," said Elliott. "This is part of our overall effort to offer a comprehensive range of bearing surfaces, including our industry-leading highly crosslinked polyethylene as well as metal-on-metal and ceramic-on-ceramic options."

Zimmer originally submitted its request for clearance to market the Trilogy AB products in December 2004.

Also see; repairing an artificial hip.

About The Author:

Jeff Nagel is a successful author and regular contributor to http://www.hip-replacement-care.com. As an Orthopaedic Resident, he has taken care of patients undergoing hip replacements and assisted many of these procedures and has extensive surgical knowledge.