Paragon 28 gets IDE from FDA for Its SMART Total Talus combo with the APEX 3D

Paragon 28 announced they have received an Investigational Device Exemption, IDE, approval from the 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 System. The study is expected to begin in early 2024. This milestone is an important achievement in the advancement of Paragon 28’s SMART 28SM strategy, which targets to provide meaningful options to their surgeon customers and significantly improve patient outcomes. The IDE of the SMART Total Talus adds to the company’s existing Patient Specific Total Talus offering by expanding use of the technology as an option for prospective total ankle replacement candidates.