December 13, 2021
ENGLEWOOD, Colorado– (COMMERCIAL THREAD) –Paragon 28, Inc. (NYSE: FNA) announced today that it has received an additional approval order from the United States Food and Drug Administration (“FDA”) for the Patient Specific Talus Spacer. The Supplemental Order of Approval allows the patient specific spacer to be additively fabricated from a titanium alloy with a titanium nitride coating.
The Patient Specific Talus Spacer was first approved on February 17, 2021 by the FDA under a humanitarian device exemption for the treatment of avascular necrosis of the ankle joint. Originally approved in a cobalt-chromium metal alloy, the implant is now available in titanium with a titanium nitride coating. The surgeon selects the material best suited to his patient.
The patient-specific talus spacer remains the first and only patient-specific total talus replacement implant approved for use in the United States. The implant is designed to replace the talus, an ankle bone that connects the leg and foot, providing patients with access to a new joint-preserving alternative to amputation or traditional ankle fusion therapies.
Professor of Orthopedic Surgery at Duke University and Director of Digital Strategy and Innovation, Selene Parekh, MD, MBA, explained, “We are giving patients hope for a better quality of life through this surgery. . “
Albert DaCosta, President and CEO of Paragon 28, said, “P28 now has extensive material options available for the first and only FDA-approved patient-specific total talus replacement implant. P28 will continue to invest in patient-specific solutions to help surgeons address unique and complex clinical challenges. We thank the FDA for a great partnership during this process. “
Patient-Specific Heel Spacer reinforces Paragon 28’s Precision Ankle Solutions product offering, which includes the APEX 3D ™ Total Ankle Replacement System, MAVEN ™ Patient-Specific Guides, Fracture Plate System the Gorilla® Ankle, the Silverback® Ankle Fusion Plate System and Phantom ™ TTC Fusion Nail Systems. With this comprehensive portfolio, Paragon 28 provides its customers with innovative ankle solutions for trauma, arthritis and limb rescue.
About Paragon 28, Inc.
Based in Englewood, Colorado, Paragon 28® is a leading medical device company focused exclusively on the foot and ankle orthopedics market and dedicated to improving the lives of patients. From the start, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instruments that cover a wide range of foot and ankle conditions, including fracture fixation, hallux valgus (bunions), hammer toe, ankle, progressive deformation of the foot (PCFD) or flat foot, charcot foot and orthobiology. The company designs products with both the patient and the surgeon in mind, with the goal of improving outcomes, reducing rates of disease recurrence and complications, and making procedures simpler, consistent and reproducible.
Matt Bacso, CFA