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Portland Orthopaedics Wins US FDA Approval to Market NewPrimary Hips

27 / 07 / 2006

First US sales order expected within weeks

Portland Orthopaedics Limited (ASX:PLD) has been granted US Food and Drug Administration (FDA) approval to market the company's new M-COR primary hip in the US. The company will now ramp-up its manufacturing in preparation for delivery of its extended orthopaedic range to its exclusive US distributor, Plus Orthopedics Inc.

Portland's M-COR primary hip has the advantage of modular design and a distinct neck component, that improves the fit and adjustability of a primary hip replacement and which can lead to increased longevity of the implant. The M-COR primary hip is fixed in the thigh bone (femur) with a traditional hammer and nail method that is very familiar to orthopaedic surgeons, but has unique and patented methods for assisting the surgeon to obtain ideal fit for each person's anatomy.

"This is a major regulatory milestone for Portland. It is a green light for Portland to sell and implant its most important hip product throughout the US. The hybrid design of the M-COR includes some of the innovative features of Portland's revision hip while keeping the familiar interference fit method. This product is based on four years of market experience and has attracted significant interest from Plus and a small sample of US surgeons." said Mr David Sekel, Managing Director of Portland Orthopaedics.

"Portland will now be equipped to service revision hip replacement surgery as well as mass market primary hip replacements. Importantly, this makes Portland much more attractive to global hip and knee distributors as now we have a more complete suite to offer."

The product and instrumentation was principally designed by Portland's US Clinical Advisory Panel but will be manufactured in Sydney, Australia.