Posted by Michael Wonder on 18 Feb 2021
Additive Orthopaedics announces FDA approval of patient specific talus spacer, first approved in the U.S.
17 February 2021 - Company can now initiate commercial marketing, sale, and distribution of patient specific talus spacer implants.
Additive Orthopaedics announced today it has received an approval order from the U.S. FDA for its humanitarian device exemption 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.
