FDA Approves 3D-Printed Talus Implant for Humanitarian Use

The FDA has approved Additive Orthopaedics’ Patient Specific Talus Spacer, an implant for replacing the talus bone to treat avascular necrosis of the ankle joint, as a humanitarian use device.

The patient-specific 3D-printed implant offers an alternative to joint fusion or below-the-knee amputation for the painful, progressive condition that causes a lack of blood supply and leads to the death of bone tissue.

The device was approved under the agency’s humanitarian device exemption process, meaning it is intended to treat a disease or condition that affects no more than 8,000 patients per year.