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(MENAFN - PR Newswire) LITTLE SILVER, N.J., Feb. 17, 2021 /PRNewswire/  Additive Orthopaedics, LLC., announced today it has received an approval order from the U.S. Food and Drug Administration ( FDA ) for its Humanitarian Device Exemption ( HDE ) application for the Patient Specific Talus Spacer for treatment of avascular necrosis of the talus. The approval order makes the Additive Orthopaedics Patient Specific Talus Spacer the first and only patient specific total talus replacement implant approved by the FDA for use in the United States. Continue Reading
(PRNewsfoto/Additive Orthopaedics, LLC.)
The Patient Specific Talus Spacer is indicated for Avascular Necrosis ( AVN ) of the ankle joint. Under the HDE, the Patient Specific Talus Spacer will be made available as a humanitarian use device, defined by the FDA as one intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individual ....

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