Approval comes for orthopedic implantable device manufactured with metal injection molding technology.
Maetta Sciences officials are pleased to announce that FDA clearance has been obtained for a cobalt chrome orthopedic implantable device manufactured with its proprietary metal injection molding (MIM) technology. This project was developed in close collaboration with one of the company’s large OEM customer. The company plans to rapidly start the production of this device for market introduction this fall.
Maetta moved in March 2013 to a brand new 15,000ft manufacturing facility located in Varennes on the south shore of Montreal, Quebec, Canada, where it already manufactures medical instruments 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 flow to comply to the specifics of implantable devices.
“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,” says Serge Bragdon, chairman of the board.
“It is a great achievement by our team as we believe this is the first time FDA clearance is 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,” states Yvan Beaudoin, president and CEO.
The company holds ISO 13485; 2003, AS9100: 2009 and ISO 9001: 2008 certification. It is specialized in high end materials such as cobalt chrome, titanium alloys, and nickel super alloys.
Source: Maetta Sciences