Paragon 28 receives FDA approval for APEX 3D total ankle replacement system

Wednesday July 15, 2020 0 comments Tags: Englewood, Paragon 28, APEX 3D, Albert DaCosta

ENGLEWOOD – Paragon 28 announced its 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-logo  

Paragon 28 said it 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.

"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,” said Mark Dalton, an APEX 3D design surgeon. 

“This system was designed from day one to meet these goals."

"P28 remains committed to providing better outcomes in all aspects of foot and ankle surgery,” said Albert DaCosta, Paragon 28's president and CEO. 

“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."