IsoTis Inc. announced today that the U.S. Food And Drug Administration approved its Accell family of products to be marketed as U.S. Class II medical devices.
The products are used as bone graft extenders in the spine, extremities and pelvis or as bone void fillers in the extremities and pelvis. Class II approval means the FDA requires extra controls for the products such as special labeling, mandatory performance standards and postmarket surveillance.
IsoTis, originally based in Switzerland, made Irvine its international headquarters this year and is consolidating its research and manufacturing here. The company announced earlier this month it is being bought by Integra LifeSciences Holdings Corp. in Plainsboro, N.J. for $51 million.
