J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

October 16, 2023
11:51 am

CrossRoads Extremity Systems, which J&J acquired in 2022, submitted the 510(k) filing for the TriLEAP plating system earlier this year. The device is designed to accommodate multiple screw diameters and features procedure-specific plate options.

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.

J&J receives 510(k) clearance for foot fixation device, targets growing bunion market

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