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Novastep gains approval for its implants in the United States

Novastep, a company that manufactures implants and medical devices for foot and ankle surgery is highly focused on exporting its products, in particular to the United States. In order to meet new requirements from the Food and Drug Administration (FDA), the company called on Cetim's experts to characterise the corrosion susceptibility of the superelastic compression foot staple system (Arcad range) in accordance with standard ASTM F2129. The aim of this standard is to determine the corrosion susceptibility of small implant devices using nitrogen. The company chose Cetim so as to "be able to monitor the test from start to finish, while working with the experts of the centre to understand both the results obtained and the methods of improving our products if necessary", explained Loïc Girod, R&D Manager. This was a wise choice as the staples of the Arcad range were immediately approved by the American authorities.

 
Read the reference sheet "Novastep – Implants that comply with US standards" on our website in the "References" section.
(04/04/2018)

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