New Ionbond coating center in Switzerland for coating implant devices recently received Premarket Approval (PMA) and Premarket Notification (510(k)) by FDA

13 February 2020

PA-CVD, PVD-Arc/Sputtering/HIPIMS technologies are offered in the newly refurbished IHI Ionbond coating center in Dulliken, Switzerland. The Dulliken site holds ISO 9001, ISO 14001 and ISO 13485 certifications. More than 15 years of experience in coating medical devices, fully validated processes and machinery, as well as state-of-the-art coating and analysis technologies serve the growing demand of medical coatings. “Applying coating on orthopedic and spine implants requires a properly validated coating design and controlled process flow performed in an adequate environment. This is the case at Ionbond facilities in Switzerland, the USA and China, allowing us to develop the market in these three regions” says Dr. Antonio Santana, Global Head Medical Segment at Ionbond.  

Ionbond Switzerland has coated for many years the 7 layer coating for Aesculap. Recently Medthin 42 and Medthin 01 were approved by FDA through PMA and 510(k), respectively.

Medthin 42 DLC and Medthin 43 ADLC are applied on award winning spine devices. Medthin 42 coated devices were evaluated by FDA to demonstrate the safety and probable clinical benefits of the less invasive, non-fusion deformity spine correction system.

“In recent years we have collected results from clinical trials and many simulator tests from coated devices - such data allows us to design adequate coatings to reduce wear and ion release, and thus substantially increase the probability for patients to avoid inflammatory processes over the short, medium and long term”, said Dr. Susann Schmidt, Segment Engineer for Medical applications.

 

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