Paragon 28 received an Investigational Device Exemption (IDE) approval from FDA to commence a feasibility study for configurations of the SMART Total Talus System used in conjunction with the Paragon 28 APEX 3D Total Ankle Replacement. The study is expected to begin in early 2024.
Paragon 28 acquired Additive Orthopaedics in 2021, providing the company with the first and only FDA approved Patient Specific Total Talus replacement for treatment of avascular necrosis. With approval of the IDE to support future regulatory applications, the company’s SMART Total Talus is on the path to become the only device on the market intended for talar replacement in the setting of adjacent joint arthritis.
Paragon 28 received an Investigational Device Exemption (IDE) approval from FDA to commence a feasibility study for configurations of the SMART Total Talus System used in conjunction with the Paragon 28 APEX 3D Total Ankle Replacement. The study is expected to begin in early 2024.
Paragon 28 received an Investigational Device Exemption (IDE) approval from FDA to commence a feasibility study for configurations of the SMART Total Talus System used in conjunction with the Paragon 28 APEX 3D Total Ankle Replacement. The study is expected to begin in early 2024.
Paragon 28 acquired Additive Orthopaedics in 2021, providing the company with the first and only FDA approved Patient Specific Total Talus replacement for treatment of avascular necrosis. With approval of the IDE to support future regulatory applications, the company’s SMART Total Talus is on the path to become the only device on the market intended for talar replacement in the setting of adjacent joint arthritis.
Copy to clipboard 
