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Surgical Technology

U.S. FDA clears disposable spacer molds for knee revision surgery

Published in Medical Letter on the CDC and FDA, August 28th, 2005

Biomet, Inc., (BMET) announced that the U.S. Food and Drug Administration has granted marketing clearance for its patented StageOne Disposable Spacer Molds for knee revision surgery.

The StageOne spacer molds are a series of silicone molds designed to be used in revision knee surgery following infection. Currently, when performing the first stage of a two-stage revision, surgeons must hand make bone cement spacers to provide a temporary knee joint.

"The StageOne spacer molds will provide the orthopedic surgeon with greater component accuracy while significantly reducing O.R. time," stated Biomet's president & CEO, Dane A. Miller, PhD. "The StageOne...

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