![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Approves 3D-Printed Talus Implant for Humanitarian Use
FDA Approves 3D-Printed Talus Implant for Humanitarian Use
![Purple_Approved_Stamp.gif](https://www.fdanews.com/ext/resources/test/Drug-Images4/Purple_Approved_Stamp.gif?t=1576639773&width=430)
February 19, 2021
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.
Upcoming Events
-
21Oct