- Johnson & Johnson has received 510(k) clearance for a plating system for foot and ankle procedures.
- The Food and Drug Administration cleared the system, TriLEAP, after concluding it is substantially equivalent to a device that Synthes, now part of J&J, brought to market in 2010.
- J&J is targeting elective and trauma procedures, including the “fast growing” bunion market. The 510(k) clearance comes shortly after Stryker introduced a minimally invasive system for treating bunions.
CrossRoads Extremity Systems, which J&J acquired in 2022, submitted the 510(k) filing for the TriLEAP plating system earlier this year. It received clearance in September for adults and adolescents aged 12 to 21 years. J&J called the device “a comprehensive yet modular, procedure-specific system designed to meet the complex needs of orthopedic surgeons, doctors of podiatric medicine, and foot and ankle specialists.”
The device is designed to accommodate multiple screw diameters and features procedure-specific plate options. J&J sees the adaptability of the system as a way to support a range of procedures that involve the reduction, internal fixation and fusion of bones and bone fragments.
Trauma procedures are one application, but J&J’s statement focuses more on the role of the device in elective procedures. Estimating that one in four people in the U.S. have bunions, J&J sees bunionectomies and other elective foot surgeries as a growth opportunity for its DePuy Synthes orthopedic unit.
Other companies are also targeting the bunion market. Stryker strengthened its position in extremity orthopedic devices through its $4 billion takeover of Wright Medical and recently launched an internal fixation system for treating bunions. J&J will begin selling its TriLEAP system in the U.S. next year.