Paragon 28, Inc. Circular External Fixation System Cleared by FDA

Rhea-AI Summary

Paragon 28, Inc. (NYSE: FNA) has received 501(k) marketing clearance from the FDA for its Circular External Fixation System, set to launch commercially in early 2022. This marks the company's first external fixation product and will expand its existing internal fixation portfolio in the foot and ankle orthopedic sector. Brendan Shook, Executive VP of Marketing, expressed enthusiasm about the new product, which aims to improve patient outcomes in foot and ankle care.

Positive

• FDA clearance received for Circular External Fixation System.
• Expansion of the product portfolio enhances market presence in foot and ankle orthopedic solutions.

Negative

• None.

ENGLEWOOD, Colo.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211115006263/en/

Investor Contact:

Gilmartin Group

Matt Bacso, CFA

Matt.bacso@gilmartinir.com

Source: Paragon 28, Inc.

FAQ

What product did Paragon 28 receive FDA clearance for?

Paragon 28 received FDA clearance for its Circular External Fixation System.

When will the Circular External Fixation System launch?

The Circular External Fixation System is expected to launch commercially in early 2022.

How does the new product benefit Paragon 28?

The new product complements Paragon 28’s existing internal fixation portfolio, enhancing its offerings in the foot and ankle orthopedic market.

What is the stock symbol for Paragon 28?

The stock symbol for Paragon 28 is FNA.