News

Acusure® Technology gains further approval for use in the USA

21 January 2013

Oxford, 21 January 2013 … Accentus Medical is pleased to announce that one of its customers, FHi, a member of the FH Orthopedics Group, a long established French manufacturer of orthopaedic implants, recently gained a 510(K) approval from the US Food and Drug Administration (FDA) for its Arrow Reverse Total Shoulder prosthesis. This product incorporates the proprietary Acusure® inert gas plasma spray coating, applied by Accentus Medical at our facility in Harwell. This is the latest product approval obtained by our customers for free sale of Acusure® coated products in the United States of America.

Thomas Salomon, Accentus Medical’s sales representative in France and Switzerland, explained "FHi are one of an increasing number of companies from within the UK, mainland Europe and the Pacific rim who have recently started to use Accentus Medical as a coating supplier. They have been attracted by the comprehensive Acusure® technical Masterfile that Accentus Medical has placed with the FDA. The company works closely with device manufacturers to understand their coating requirements and the Masterfile enables them to reference this comprehensive data in support of device submissions in a timely and efficient manner to obtain approval."

James Armstrong, Business Development Manager for Accentus Medical, went on to say "There are already several hip products with our Acusure® coating, approved by the FDA, and several more in the pipeline. However this is a landmark in that it is the first upper limb prosthesis that we can add to a growing list of approvals for products incorporating the Acusure® technology."

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For further information, please contact:
Thomas Salomon
Accentus Medical
T: +44 (0)1235 434320
Email: thomas.salomon@accentus-medical.com

About Accentus Medical
Accentus Medical is a leading medical technology company that combines a long history of expertise in surface coating and modification technologies with dedicated research and development of new technologies for the medical device industry. With roots in the
United Kingdom Atomic Energy Authority, and based at the historic Harwell Oxford campus, Accentus Medical has provided expertise in surface technologies to the orthopaedic device industry since the 1970s, serving major orthopaedic and medical device manufacturers worldwide.

The company works closely with industry partners to develop new surface technologies that address unmet market needs, and is renowned for its experienced staff and track record for responsive, high quality service. The services offered include hydroxyapatite and metal alloy coatings (known as Acusure®) using a plasma spray process at Accentus Medical’s ISO 13485:2003 and ISO 9001:2008 accredited facility. Accentus Medical is also very well known for the medical device testing programmes offered by its in-house test laboratories. Manufacturers have been utilising test results provided by the company for many years as part of device homologation files all over the world.

For further information, please visit: www.accentus-medical.com

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