The Patient Specific Talus Spacer was first approved on February 17, 2021, by the FDA under a Humanitarian Device Exemption for treatment of avascular necrosis of the ankle joint
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Paragon 28 announced today that it has received a supplemental approval order from the U.S. Food and Drug Administration (“FDA”) for the Patient Specific Talus Spacer. The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating.
The Patient Specific Talus Spacer was first approved on February 17, 2021, by the FDA under a Humanitarian Device Exemption for treatment of avascular necrosis of the ankle joint. Originally approved in cobalt chromium metal alloy, the implant is now available in titanium with a titanium nitride coating. The surgeon selects which material is best suited for his/her patient.
The Patient Specific Talus Spacer remains the first and only patient specific total talus replacement implant authorized for use in the United States. The implant is designed to replace the talus, an ankle bone that connects the leg and foot, providing patients access to a novel, joint-sparing alternative to amputation or traditional ankle fusion therapies.
Duke University Professor of Orthopaedic Surgery and Director of Digital Strategy & Innovation Selene Parekh, MD, MBA explained, “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 Patient Specific Talus Spacer bolsters Paragon 28’s Precision Ankle Solutions product offering, which includes the APEX 3D™ Total Ankle Replacement System, MAVEN™ Patient Specific Guides, Gorilla® Ankle Fracture Plating System, Silverback® Ankle Fusion Plating System, and Phantom™ TTC Fusion Nail Systems. With this comprehensive portfolio, Paragon 28 provides its customers innovative ankle solutions for trauma, arthritis, and limb salvage.
Source: Company Press Release