FDA approves first in the world, first-of-its-kind implant for the treatment of rare bone disease as a humanitarian use device

FDA

17 February 2021 - Today, the U.S. FDA approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. 

The Patient Specific Talus Spacer is 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 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 avascular necrosis that may disable motion of the ankle joint.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , US , Device