Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System

By Julie A. Vetalice

Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System

Carbon22 was granted FDA 510(k) clearance to market the FusionFrame™ Ring Lock circular external fixator.

FusionFrame enables customization of frames specific to patient needs. This system can treat complex foot and ankle deformities, as well as provide a static frame for various indications. Future variations are under development.

“As we continue to develop our new, innovative patent-pending technology platforms, designed to allow for visualization of fusion sites (intraoperatively) and post-operative healing zones, we are working to ensure that foot and ankle surgeons have the right devices they need to treat today’s foot and ankle conditions,“ said Thomas H. Lee MD, Chief Medical Officer for Carbon22.

Carbon22 products are commercialized in the U.S. through exclusive distribution and education agreements with Novastep.

Product Labels: External Fixation, Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory