Medical device company Paragon 28 announces that the U.S. FDA has given 501(k) marketing clearance to its R3ACT Stabilization System.
The R3ACT Stabilization System, expected to commercially launch in early 2022, will complement Paragon 28’s comprehensive ankle fracture and soft tissue portfolio and further expands Paragon 28’s product offering in the foot and ankle space.
“Syndesmotic stabilization has been a journey to understand and more importantly to replicate. 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,” says Albert DaCosta, Paragon 28 chief executive officer and co-founder.
The addition of the R3ACT Stabilization System bolsters Paragon 28’s ankle fracture and syndesmotic product offering, which includes the Gorilla Ankle Fracture Plating System, Gorilla Pilon Plating System, Mini-Monster Screw System, and R3LEASE Stabilization System. With this comprehensive portfolio, Paragon 28 provides its customers a broad array of innovative solutions for fracture fixation and soft tissue stabilization.