Wright's hip resurfacer finally approved by FDA
This article was originally published in Clinica
Executive Summary
The US FDA has granted premarket approval (PMA) for the Conserve Plus hip resurfacing system developed by Wright Medical after a wait of more than five years. The total surface arthroplasty system, a bone-conserving alternative to traditional total hip replacement, was submitted for FDA approval in early 2004. Arlington, Tennessee-based Wright will market Conserve Plus in the original femoral and acetabular component configuration specified in its PMA application. It will also work to introduce enhancements to the system, which are currently only available outside the US, via a PMA supplement. The US hip replacement market currently includes just two products, made by Smith & Nephew and Corin.
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