FDA OKs DePuy Synthes’ TriLEAP Lower Extremity Plating System

DePuy Synthes has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its TriLEAP lower extremity anatomic plating system for forefoot, midfoot, and hindfoot elective and trauma surgeries.
 
The modular, procedure-specific TriLEAP system features a range of contoured and conventional plates that can accommodate various screw diameters, and its instruments can be used during reduction, internal fixation, and fusion of bones and bone fragments.
 
The company said TriLEAP was designed to meet the complex need of orthopedic surgeons, doctors of podiatric medicine, and foot and ankle specialists. DePuy Synthes said it anticipates product release in the U.S. in 2024.
 
“As a leader in elective foot and ankle procedures, DePuy Synthes is dedicated to developing novel solutions tailored to the changing needs of both patients and surgeons,” Oray Boston, Worldwide President, DePuy Synthes Trauma, Extremities, Craniomaxillofacial, Animal Health and Sports, told the press. “The development and clearance of the TriLEAP Lower Extremity Anatomic Plating System is a prime example of how we are maintaining our speed of innovation in the space to address unmet needs and help achieve the best possible outcomes for patients.”
 
Earlier this week, the company secured FDA 510(k) clearance for its TriALTIS spine system and navigation-enabled instruments.