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FDA approves novel 3D-printed talus implant for humanitarian use
Today, the U.S. Food and Drug Administration 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 (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.
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SILVER SPRING, Md., Feb. 17, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration 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 (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.
Image by Anna - Adobe Stock The OPRA Implant System has been on the market under a humanitarian device exemption since 2015 and is now fully approved by FDA for patients who have trouble with conventional socket prosthetics.
FDA approved the first implant system for adults who have above-the-knee amputations and might not be able to use a conventional socket prosthetic device.
The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, has been on the U.S. market since 2015 under a humanitarian device exemption, and FDA blessed the prosthetic device with a pre-market approval in late December. The approval expands options for people with above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses, according to Capt. Raquel Peat, PhD, director of FDA s Center for Devices and Radiological Health s Office of Orthopedic Device
FDA approves first implant system for adults who have above-the-knee amputations
The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral or above-the-knee amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
Today s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses. Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities.