It was reported on Wednesday that United States-based Additive Orthopaedics LLC has received approval from the United States Food and Drug Administration (FDA) for the Patient Specific Talus Spacer 3D-printed talus (ankle bone) implant for humanitarian use.

The product is a 3D printed implant that can be used in talus replacement surgery. The talus spacer is made individually for each patient, modelled from computed tomography imaging, and is fitted to a patient's specific anatomy. The Patient Specific Talus Spacer is claimed to be the first in the world and first-of-its-kind implant to replace the talus, the bone in the ankle joint that connects the leg and the foot, for the treatment of avascular necrosis (AVN) of the ankle joint, a serious and progressive condition that causes the death of bone tissue stemming from a lack of blood supply to the area.

The US FDA has reviewed data for the Patient Specific Talus Spacer via the humanitarian device exemption process.