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Ionbond Coating Center Receives FDA PMA and 510(k)

Ionbond received FDA Premarket Approval and 510(k) clearance for its new center in Switzerland for coating implant devices.

Specifically, the company received regulatory approval of Medthin™ coatings 42 and 01.

Medthin 01 TiN is suitable for coating on UHMWPE and for Coating on Coating contact in orthopedic and spine applications, as well as trauma and fixation components made of titanium and stainless steel.

Medthin 42 DLC and 43 ADLC are applied on spine devices in applications where high wear resistance and very low friction are required. They are ideally suited for coating various component geometries and surface textures on all commonly used metal alloys such as stainless steels, titanium and CoCrMo. Medthin 42 shows superior scratch resistance vs. other DLC coatings, making it ideal for instruments.

Medthin 42-coated devices have been evaluated by FDA to demonstrate the safety and probable clinical benefits of less invasive, non-fusion deformity spine correction systems.

Ionbond Switzerland, which is certified to ISO 9001, ISO 14001 and ISO 13485, offers PA-CVD, PVD-Arc, Sputtering and High Power Impulse Magnetron Sputtering.

“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 at Ionbond.