Paragon 28 Gains FDA Clearance for APEX 3D Total Ankle

By Julie A. Vetalice

Paragon 28 Gains FDA Clearance for APEX 3D Total Ankle

Paragon 28 received FDA 510(k) clearance to market the APEX 3D™ Total Ankle Replacement system, featuring porous 3D-printed implants and Vitamin E infused highly cross-linked polyethylene.

APEX 3D offers choices in instrumentation, alignment techniques and implant selection, including ARC™ or flat tibia trays and either chamfer or flat talar components.

The device complements the company's Precision Ankle Solutions offerings, which include Gorilla® Ankle Fracture Plating, Silverback® Ankle Fusion Plating and Phantom™ TTC Fusion Nail Systems.

Albert DaCosta, Paragon 28's President and CEO, said, "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."

Product Labels: Ankle Replacement

Tags: 510(k) Clearance, Regulatory