FDA OKs ceramic-on-ceramic bearing hip replacement

The medical device regulator approves Zimmer Holdings’ PMA for their hip replacement system, designed to treat patients with noninflammatory arthritis.

A ceramic-on-ceramic acetabular hip replacement system from Zimmer Holdings Inc. received final FDA approval July 6 and will be available to U.S. health care professionals by the end of the month.

Zimmer designed the implant, the Trilogy AB (Alternate Bearing) Ceramic-on-Ceramic Acetabular System, for either cemented or noncemented hip replacements. The company hopes to launch its new product within two weeks, according to a company press release. The replacement system targets older patients who are candidates for total hip replacement due to noninflammatory arthritis, such as avascular necrosis, traumatic arthritis and osteoarthritis. The FDA action, in effect, approves Zimmer's Premarket Approval Application for the implant.

The system consists of a metal hip stem, a ceramic femoral head, a metal acetabular cup and a ceramic insert that fits into the acetabular cup. As an alternate bearing solution for surgeons, the Trilogy AB has a hemispherical fiber metal porous-coated shell (HG-I and HGP-II) combined with the performance of alumnia/alumin bearing couples, Zimmer officials said in a press release.

Zimmer originally submitted their request for approval of the Trilogy AB to the FDA in December 2004. The company received an “approvable” letter from the FDA in November 2005, subject to an FDA facilities inspection. Zimmer has sold the Trilogy AB outside the United States since 2001.

Zimmer also began marketing another alternate bearing implant device for hips in June: the Durom Acetabular Component for metal-on-metal articulation with Metasul LDH (large-diameter femoral heads).