Paragon 28 receives FDA clearance for ankle fracture, soft tissue stabilization system
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Paragon 28 Inc. has announced FDA 510(k) clearance of the R3ACT syndesmotic stabilization system, according to a press release.
The R3ACT system includes a portfolio of products designed for foot and ankle fractures and soft tissue injuries, according to the release. The system is expected to commercially launch in early 2022.
“Syndesmotic stabilization has been a journey to understand and more importantly to replicate,” Albert DaCosta, CEO and co-founder of Paragon 28, said in the release. “We are excited to have developed a product that we believe addresses the complex needs of this indication and mimics not only the dynamic environment of the syndesmosis but also transitions the function of stabilization to best match the healing phases of the soft tissues,” DaCosta said.
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