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FDA OKs Paragon 28’s R3ACT Stabilization System

Bolsters the firm's ankle fracture and syndesmotic product offering.

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By: Sam Brusco

Associate Editor

Paragon 28 earned FDA 510(k) clearance to market its R3ACT Stabilization System. The company intends to launch it in early 2022, complementing a comprehensive ankle fracture and soft tissue portfolio.
 
“Syndesmotic stabilization has been a journey to understand and more importantly to replicate,” Paragon 28 CEO and co-founder Albert DaCosta told the press. “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.”
 
Adding the R3ACT Stabilization System bolsters the firm’s ankle fracture and syndesmotic product arsenal, which is comprised of the Gorilla Ankle Fracture Plating System, Gorilla Pilon Plating System, Mini-Monster Screw System, and R3LEASE Stabilization System.

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