Sam Brusco, Associate Editor12.14.21
Paragon 28 received a supplemental approval order from the U.S. Food and Drug Administration (FDA) for its Patient-Specific Talus Spacer, allowing it to be additively manufactured using titanium alloy with a titanium nitride coating.
The device was initially approved on February 17 under Humanitarian Device Exemption to treat ankle joint avascular necrosis. It was originally approved in a cobalt chrome alloy. The additional approval for titanium with a titanium nitride coating lets surgeons choose which material is best suited for their patients.
According to the company, the Patient-Specific Talus Spacer is the first and only patient-specific total talus replacement authorized for use in the U.S. The implant replaces the talus, the ankle bone connecting the ankle and foot.
Duke University Professor of Orthopaedic Surgery and Director of Digital Strategy & Innovation Selene Parekh, MD, MBA told the press, “We are giving patients hope for a better quality of life with this surgery.”
Albert DaCosta, president and CEO of Paragon 28, commented, “P28 now has expanded material options available for the first and only FDA approved patient specific total talus replacement implant. P28 will continue to invest in patient specific solutions to help surgeons address unique and complex clinical challenges. We thank the FDA for a tremendous partnership during this process.”
The device was initially approved on February 17 under Humanitarian Device Exemption to treat ankle joint avascular necrosis. It was originally approved in a cobalt chrome alloy. The additional approval for titanium with a titanium nitride coating lets surgeons choose which material is best suited for their patients.
According to the company, the Patient-Specific Talus Spacer is the first and only patient-specific total talus replacement authorized for use in the U.S. The implant replaces the talus, the ankle bone connecting the ankle and foot.
Duke University Professor of Orthopaedic Surgery and Director of Digital Strategy & Innovation Selene Parekh, MD, MBA told the press, “We are giving patients hope for a better quality of life with this surgery.”
Albert DaCosta, president and CEO of Paragon 28, commented, “P28 now has expanded material options available for the first and only FDA approved patient specific total talus replacement implant. P28 will continue to invest in patient specific solutions to help surgeons address unique and complex clinical challenges. We thank the FDA for a tremendous partnership during this process.”