Bio2 Technologies Receives FDA Clearance for Extremities Fusion Implant

By Julie A. Vetalice

Bio2 Technologies received FDA 510(k) clearance to market a fusion system for interphalangeal fusion, fracture repair and osteotomies of toes, fingers and other small bones in the presence of appropriate immobilization. The implants are made from Vitrium biomaterial, composed of resorbable bioactive glass. Limited product launch is slated for 2Q16.

BIo2 has designed its Vitrium technology as an alternative to allograft and other materials, such as DBM, ceramics, polymers and BMPs.

Source: Bio2 Technologies, Inc.

We first noticed Bio2 in 2010, following its first round of funding. The company announced FDA 510(k) clearance for its CLM (Cross-Linked Microstructure) Bioactive Scaffold at the end of 2014. The CLM process bonds bioactive glass fiber into a rigid, 3-dimensional structure.

Product Labels: Trauma Ankle/Foot/Toe, Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory