Portland's primary knee replacement:
This article was originally published in Clinica
Executive Summary
Australia's Portland Orthopaedics has received US FDA 510(k) clearance to sell its primary knee replacement, Beacon. The device, licensed from US firm Signal Medical, is for use as a first-time knee replacement. The Sydney-based firm plans to use the product as a manufacturing platform, together with a Aus$1.9m (US$1.4) Industry grant, to develop a revision knee. The revision knee, designed for people with poor bone quality who need a greater modularity and fixing capability, will be a "higher margin product with distinct points of difference in the market", said Portland, which expects CE-marking of Beacon the product to be "imminent".
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