FDA turns down Stryker's osteogenic bone implant
This article was originally published in Clinica
Executive Summary
The US FDA has declined to approve Stryker's PMA for its OP-1 implant for use in the treatment of nonunion fractures of the tibia. The thumbs-down comes just four weeks after the EU's Committee for Proprietary Medicinal Products recommended approval (see Clinica No 942, p 19).