Bio2 Technologies announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Fusion Implant system for interphalangeal fusion, fracture repair and osteotomies of the toes, fingers and other small bones in the presence of appropriate immobilization.
The implants are constructed with Bio2’s Vitrium biomaterial exclusively composed of bioactive glass, a resorbable material with a well-studied mechanism of action and long track record of safe clinical use.
Following years of research and pre-clinical testing, Bio2 has successfully applied its proprietary process technology to produce a rigid, bioactive and osteoconductive material with an interconnected porous structure that facilitates ingrowth and remodeling of healthy bone.
Paul Nichols, President and Chief Executive Officer of Bio2 Technologies, stated "the Fusion Device is our second market clearance of a Vitrium product application, joining our line of osteotomy wedges for reconstructive surgery of the mid and hind foot in our extremities portfolio.
"We believe the properties of Vitrium offer musculoskeletal surgeons an attractive alternative to allograft (cadaver bone) and synthetic materials such as beta-tricalcium phosphate."
A limited product release of the Fusion Device is planned for the second quarter of 2016.