Portland Orthopaedics Lodges FDA Application To Implant New Primary Hip Replacements

Sydney-based Portland Orthopaedics Limited (ASX: PLD) has lodged an application with the US Food and Drug Administration (FDA) for approval to market the company's new M-COR primary hip product range in patients in the US. Portland Orthopaedics received its first FDA approval for the DTC Hip in 2000 and in 2005 was granted FDA approval for use of its second product, the Equator Plus Cup.

The FDA Pre Market Approval (510k) approval process typically takes 90 days from lodgement and it is expected that the first M-COR primary hip implant on a US patient will take place shortly thereafter.

Portland is best known for its revision hip products used in patients typically with poor bone quality where the common styles of artificial hips are often unsatisfactory. Listed on 21 December 2005, Portland raised $4.1 million in its initial public offering to expand its hip and knee replacements to offer a suite of products to surgeons.

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. In addition Portland's primary hip maintains the advantages of both modular design and a distinct neck component that improves the fit and adjustability which can increase longevity. Surgeons in the US are assisting Portland with design and the product instrumentation.

“This hybrid design includes some of the innovative features of Portland's revision hip while keeping the familiar interference fit method. This is a pragmatic business decision based on our four years of hip product distribution in the US,” said Mr David Sekel, MD of Portland Orthopaedics.

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

All Portland's products are designed and principally manufactured at its facility in Sydney.

Also see; artificial hip joints.

About The Author:

David Sekel is a successful author and regular contributor to http://www.hip-replacement-care.com. Information on hip replacement; the cause, diagnosis, symptoms, surgery and treatment for recovery and rebuilding your body.