Medical Device Daily Associate Managing Editor

Zimmer Holdings (Warsaw, Indiana) reported that it has received approval of its premarket approval (PMA) application from the FDA to market the Trilogy AB ceramic-on-ceramic acetabular system, marking the first time the company has had a ceramic-on-ceramic hip option available in the U.S.

The device has been available in Europe since 2001.

In late 2005, the FDA issued an approvable letter indicating that the PMA was approvable subject to FDA inspection of the company's manufacturing facilities related to the Trilogy device (Medical Device Daily, Dec. 15, 2005).

“We are very pleased to now be able to offer a ceramic-on-ceramic acetabular option to our customers in the U.S,“ Ray Elliott, Zimmer Holdings chairman, president and CEO said in a company statement. “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.“

He added: “We will now be able to address our customers' needs for a wide spectrum of bearing surfaces, from our industry leading Longevity Highly Crosslinked polyethylene to our new Durom/Metasul LDH metal-on-metal option and, now, Trilogy AB ceramic-on-ceramic.“

In a ceramic-on-ceramic hip replacement system, a ceramic femoral head mates with a ceramic cup liner to form the ball-and-socket articulating couple. Most hip replacement systems employ a metal femoral head that articulates with a polyethylene cup liner.

While declining to give specific projections on how much revenue the company expects to garner in the U.S. for the Trilogy, Zimmer spokesperson Brad Bishop told Medical Device Daily that in general, physicians prefer to use ceramic-on-ceramic hips in a “younger patient population,“ though he said that usage may also depend largely on physician preference for a certain material.

While not available for an interview for this story, Elliott has previously stated his view that the ceramic-on-ceramic hip system “will remain a niche option, primarily for younger patients.“

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 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.

Zimmer's Metasul bearing technology was first introduced in 1988 and is a forged, high-carbon, cobalt-chromium alloy product. These characteristics have established the technology as the industry standard for strength and low metal-on-metal wear, the company said.

The company was able to submit its PMA in December 2004 without having to do any clinical trials of its own on the device. This was made possible via an agreement with CeramTec (Martredwitz, Germany) the previous month which allowed Zimmer to submit requests to U.S. and Canadian health officials for authorization to sell the ceramic-on-ceramic system using CeramTec-manufactured components, based on clinical reference data owned by that company (MDD, Oct. 18, 2004).

The Trilogy had previously been marketed outside North America by Zimmer with ceramic components manufactured by CeramTec, and the Cerasul ceramic-on-ceramic tribological solution from the legacy Centerpulse business.

The Trilogy AB femoral head and insert components are made of alumina ceramic and are designed to provide hard, wear-resistant articulating surfaces.