DGIMed Ortho's bone implants get FDA clearance
This article was originally published in Clinica
Executive Summary
DGIMed Ortho's drill and intramedullary nail system, for repairing fractures of long bones such as the femur and tibia, has received US FDA 510(k) clearance. These fractures are traditionally treated with rods that are inserted into the centre of a bone and locked in place with screws. However, this procedure requires X-rays to identify where the screws must be placed, and can take up to 45 minutes. DGIMed's product is a rod that releases markers from inside the bone, which indicate where the screws should enter. This can "significantly reduce" the time of surgical procedures, the Minnetonka, Minnesota firm claims.