Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

Orthopedic · 21 CFR 888.3023

Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.