PARAGON 28’S PATIENT SPECIFIC TITANIUM TALUS SPACER HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION
ENGLEWOOD, Colo.–(BUSINESS WIRE)– Paragon 28, Inc. (NYSE: FNA) 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.
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