Wright Medical Group Inc. has been awarded a $2.4 million grant from the Department of Defense to fund a clinical study of OSTEOSET T bone graft substitute pellets in combat-related open fracture wounds.
OSTEOSET T is a surgical grade calcium sulfate bone graft substitute impregnated with 4% tobramycin sulfate. The tobramycin is designed to release at a predictable rate and act as a resorbable scaffold for new bone. It is available in pellet form but is not approved for use in the United States.
According to the Wall Street Journal, surgical implant maker Synthes Inc. and Norian (a subsidiary) have agreed to pay penalties of $23 million for involvement in conducting clinical trials of a medical device without FDA authorization.
Meanwhile, Synthes agreed with the Department of HHS to sell Norian to a third party by May.