Paragon 28 R3ACT Stabilization System Cleared by FDA

By Julie A. Vetalice

Paragon 28 R3ACT Stabilization System Cleared by FDA

Paragon 28 received FDA 510(k) clearance to market its R3ACT™ Stabilization System. R3ACT is slated for launch in early 2022.

The addition of the R3ACT 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.

Paragon 28 Chief Executive Officer and Co-Founder Albert DaCosta commented, “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.”

Source: Paragon 28, Inc.

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory