Maetta orthopedic MIM device receives FDA clearance
Maetta Sciences has announced that Food and Drug Administration (FDA) clearance has been obtained for a cobalt chrome orthopaedic implantable device manufactured using its proprietary MIM technology. This project was developed in close collaboration with one of the company’s large OEM customers. The company stated that it planned to rapidly commence the production of this device for market introduction this autumn.
In March 2013 Maetta moved to a brand new 15,000 ft2 manufacturing facility located in Varennes, on the south shore of Montreal, Quebec, Canada, where it already manufactures medical instrument and aerospace components. This investment was required to continue its expansion in both medical device and aerospace markets by adding additional space and equipment as well as implementing special process flows to comply with the specific requirements for implantable devices.
Serge Bragdon, Chairman of the Board, stated, “This announcement confirms the quality of the team and the thoroughness of the development process the company has put in place. Not only does our technology generate significant cost savings to our clients, it also yields superior material properties and process robustness.”
Yvan Beaudoin, President and CEO, added, “It is a great achievement by our team as we believe this is the first time FDA clearance has been obtained for an implantable device made by MIM. It is also very encouraging as Maetta is currently involved in the development of several implantable devices with various clients.”
The company holds ISO 13485; 2003, AS9100: 2009 and ISO 9001: 2008 certifications and is specialised in high end materials such as cobalt chrome, titanium alloys and nickel superalloys.
Maetta’s MIM technology, states the company, combined with a sophisticated quality system, offers a distinctive proposition to industries such as medical and aerospace where there may be complex challenges such as small production volumes, highly complex shapes and stringent quality and regulatory requirements.
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