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Paragon 28, Inc. Circular External Fixation 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 today that the U.S. Food and Drug Administration (FDA) has given 501(k) marketing clearance to its Circular External Fixation System. The Circular External Fixation System, expected to commercially launch in early 2022, will complement Paragon 28’s comprehensive internal fixation portfolio and further expands Paragon 28’s product offering in the foot and ankle space.

Brendan Shook, Paragon 28's Executive Vice President of Marketing commented, "We are excited to receive FDA clearance for P28’s first external fixation product offering. We believe it will be a nice complement to our existing product portfolio, and will further P28’s mission to improve foot and ankle patient outcomes. We look forward to the product line launching in the first half of 2022."

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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