BURLINGTON, Mass.--(BUSINESS WIRE)--ConforMIS announced today that the iTotal CR received CE Mark certification on May 9, 2011, providing regulatory approval to begin introduction of the product in the European Union. The company has previously announced receipt of 510(k) Clearance for the iTotal CR from the US Food and Drug Administration back in early January.
With this clearance, all ConforMIS products including the previously launched iUni® G2 and iDuo® G2 are both US FDA 510K cleared and CE Marked, supporting the multi-regional commercial approach that has been a hallmark of the company’s strategy. ConforMIS will begin commercializing the iTotal CR in Europe in the second half of 2011.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage. Its proprietary intellectual property includes more than 250 patents and patent applications in the areas of imaging software, image processing, implant design, surgical techniques, instrumentation, and manufacturing, spanning knee, hip, shoulder, spine, and small joints. ConforMIS knee implants and instrumentation are designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. All devices have been cleared by the US Food and Drug Administration for marketing in the US and CE Marked in Europe. In 2009, ConforMIS was named a winner of the Medical Design Excellence Awards, the premier recognition for contributions and advances in the design of medical products, for its iUni and iDuo resurfacing implants. Follow ConforMIS on Twitter at @ConforMIS and become a fan on Facebook at www.facebook.com/ConforMIS.