FDA clearance for TriLEAP Lower Extremity Anatomic Plating System-- DePuy Synthes(J&J)
Johnson & Johnson MedTech announced that DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, has received 510(k) clearance from the FDA for its TriLEAP Lower Extremity Anatomic Plating System, a comprehensive yet modular, procedure-specific system designed to meet the complex needs of orthopaedic surgeons, doctors of podiatric medicine, and foot and ankle specialists.
The TriLEAP System provides a diverse offering of contoured and conventional plates that can accommodate multiple screw diameters, and instruments that can be used during the reduction, internal fixation and fusion of bones and bone fragments.
Elective foot surgeries for conditions like bunions are among the fast-growing segments of extremities procedures in orthopaedics and podiatry. In the U.S., one in four people suffer from bunions, or hallux valgus, a progressive disorder of the foot in which deformity gradually increases and can eventually compromise desired lifestyle or mobility.
Foot and ankle plating systems are implants that are used for bunionectomies, osteotomies, fusions and fractures of the foot or ankle. The systems are attached by surgeons to the affected area and are designed to stabilize the bones.
DePuy Synthes expects the TriLEAP Lower Extremity Anatomic Plating System to be available in the U.S. in 2024.
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