Healthcare Industry News: HSMN NewsFeed

Devices Orthopaedic FDA

 News Release - July 15, 2020

Paragon 28, Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the APEX 3D(TM) Total Ankle Replacement System

ENGLEWOOD, Colo., July 15, 2020 -- (Healthcare Sales & Marketing Network) -- APEX 3D™ marks the next generation in Total Ankle Arthroplasty, with advanced technologies such as porous 3D printed implants and Vitamin E infused highly cross-linked polyethylene.

Paragon 28 conducted cutting-edge biomechanical research, including a CT study of arthritic ankles to determine implant geometry and sizing, and a weightbearing CT study of healthy ankles to best match the native kinematics. The system offers choices in instrumentation, alignment techniques, and implant selection, including ARC™ or flat tibia trays and either chamfer or flat talar components.

Mark Dalton, MD, an APEX 3D™ designing surgeon, said, "Long-term implant survivorship will best be achieved with initial and ultimate implant stability, optimized articulation, improved bearing surfaces, appropriate sizing, and accurate and reproducible alignment with streamlined instrumentation. This system was designed from day one to meet these goals."

Albert DaCosta, Paragon 28's President and CEO commented, "P28 remains committed to providing better outcomes in all aspects of foot and ankle surgery. The total ankle is another giant step in fulfillment of our mission. The timing is ideal to offer the next generation of ankle technology for patients desiring a more active lifestyle."

The addition of the APEX 3D™ Total Ankle Replacement System bolsters Paragon 28's Precision Ankle Solutions product offering, which includes the Gorilla® Ankle Fracture Plating System, Silverback® Ankle Fusion Plating System, and Phantom™ TTC Fusion Nail Systems. With this comprehensive portfolio, Paragon 28 provides its customers innovative ankle solutions for trauma, arthritis, and limb salvage.

Contact Paragon 28 for more information at: info@paragon28.com


Source: Paragon 28

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