Two companies awaiting FDA approval for ceramic-on-ceramic hips

Zimmer and Biomet expect final FDA marketing approval for ceramic acetabular systems by the first quarter of 2006.

Zimmer Holdings Inc. received an letter from the FDA notifying the company that its premarket approval application for the Trilogy AB Ceramic-on-Ceramic Acetabular System is approvable pending an inspection of related facilities, according to a company press release.

Zimmer originally submitted its marketing clearance request in December 2004. The FDA has not informed Zimmer of the inspection schedule, company officials noted.

“The launch is dependent on the 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,” Ray Elliott, Zimmer Holdings chairman, president and chief executive officer, said in the press release.

The new Trilogy AB femoral head and cup liner components are made of alumina ceramic, which the company designed to provide hard, wear-resistant articulating surfaces. The system is part of Zimmer’s Trilogy Acetabular System, modeled on the Harris/Galante and HGP II Cup System designs. Zimmer introduced the system in 1994.

Earlier this year the FDA also issued a preliminary marketing approval letter to Biomet Inc. for its C2a-Taper Acetabular System.

Biomet received the letter in September and is currently awaiting a final approval order before initiating product rollout in the United States. The company expects to receive final approval by the end of this year, according to a Biomet press release.