The Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for the Patient Specific Talus Spacer 3D-printed talus implant (Additive Orthopaedics LLC).
The Patient Specific Talus Spacer is the first in the world and first-of-its-kind implant to replace the talus 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 implant provides a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN that may disable motion of the ankle joint. Current available treatments include fusing the joints in the foot and ankle together, or below-the-knee amputation.
The Patient Specific Talus Spacer is a 3D printed implant that can be used in talus replacement surgery. The talus spacer is made for each patient individually, modeled from computed tomography (CT) imaging, and is fitted to a patient’s specific anatomy. During the replacement surgery, the patient’s talus bone is removed and replaced with the implant, which is made from cobalt chromium alloy. While fusion may become necessary in the future should the condition worsen, talus replacement surgery with the Patient Specific Talus Spacer is intended to be a joint-sparing procedure, as it allows the patient to retain motion in the ankle joint.
The FDA reviewed data for the Patient Specific Talus Spacer through the HDE process. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8000 individuals in the U.S. per year.
Food and Drug Administration (FDA). FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device [news release]. February 17, 2021. Available at: click here. Accessed February 18, 2021.