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Paragon 28, Inc. R3ACT™ Stabilization System Cleared by FDA

Paragon 28, Inc. (NYSE: FNA) (“PARAGON”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that the U.S. Food and Drug Administration (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.

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.”

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.

About Paragon 28, Inc.

Based in Englewood, Colo., Paragon 28®, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, hallux valgus (bunions), hammertoe, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.


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