FDA OKs Paragon 28’s Circular External Fixation System

Paragon 28, a company exclusively focused on the foot and ankle orthopedic market, announced the U.S. Food and Drug Administration (FDA) has given 510(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.”