Paragon 28 today announced that it received a supplemental approval order from the FDA for its titanium Patient Specific Talus Spacer.
The supplemental order allows the Englewood, Colorado-based company to additively manufacture the spacer in titanium alloy with a titanium nitride coating. Paragon 28 previously received FDA approval in early 2021 under a humanitarian device exemption to treat avascular necrosis of the ankle joint using the cobalt chromium metal alloy implant.
Paragon 28’s Patient Specific Talus Spacer is a total talus replacement implant that is designed to replace the talus, which connects the leg and foot, to give patients access to joint-sparing alternatives to amputation or ankle fusion therapies.
“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,” president and CEO Albert DaCosta said in a news release.