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:
Philip Agg, CEO
T: +44 (0)1235 434328
Email: enquiries@accentus-medical.com