FDA approves 3D-printed talus implant for humanitarian use
Click Here to Manage Email Alerts
The FDA announced approval of the Patient Specific Talus Spacer, a “first-of-its-kind” 3D-printed implant for talus replacement surgery in patients with avascular necrosis, according to a press release.
The implant, constructed with cobalt chromium alloy, is modeled from CT imaging to offer specification to every patient’s anatomy, according to the release.
“Avascular necrosis of the ankle, while a rare condition, is a serious and potentially debilitating one that causes pain and can lead to inhibited motion of the ankle joint, and in some cases, removal of part of the leg,” Capt. Raquel Peat, PhD, MPH, USPHS, director of the Center for Devices and Radiological Health’s office of orthopedic devices, said in the release. “Today’s action provides patients with a treatment option that could potentially reduce pain, retain range of motion of their joint and improve quality of life,” Peat added.
Additive Orthopaedics LLC received the FDA’s humanitarian device exemption for the implant.
Click Here to Manage Email Alerts