
Johnson & Johnson Receives FDA Approval for New Foot/Ankle Plating System
Johnson & Johnson MedTech’s orthopedics division DePuy Synthes has received U.S. Food and Drug Administration (FDA) granting 510(k) clearance for their TriLEAP™ Lower Extremity Anatomic Plating System. Foot and ankle plating systems are specialized implants used in procedures such as bunionectomies, osteotomies, fusions, and fracture treatments, to provide stabilization to the bones in the foot and ankle. The TriLEAP™ System offers contoured and conventional plates suitable for a range of screw diameters to provide flexibility bone reduction, internal fixation, and fusion procedures.
Elective foot surgeries, including those addressing common issues such as bunions, represent a high growth category within the realm of orthopedic and podiatric extremities procedures. In the United States, one in four individuals contends with bunions, known as hallux valgus, a progressive foot ailment marked by the gradual deformation of the big toe joint, which can ultimately impede mobility and quality of life. There are over 350,000 bunion surgeries performed every year in the U.S. making it one of the most common elective foot surgeries.
DePuy Synthes’ Worldwide President for Trauma, Extremities, Craniomaxillofacial, Animal Health, and Sports, Oray Boston, emphasized the company’s commitment to pioneering solutions that evolve with the shifting needs of both patients and healthcare professionals. The TriLEAP™ Lower Extremity Anatomic Plating System is expected to be available to physicians and patients in the United States by 2024.