The US Food and Drug Administration (FDA) has cleared the TriLeap lower extremity anatomic plating system by Johnson & Johnson (J&J) company DePuy Synthes.
The clearance for US-based DePuy Synthes means the plating system can be used by surgeons to stabilise bones during bunionectomies, osteotomies, and fusions or fractures of the foot or ankle.
In a press release, J&J said DePuy Synthes expects to roll out the device in the US in 2024.
Bunions are one of the most common foot problems, affecting around one-third of older American adults. There are around 350,000 bunion surgeries performed in the US each year. Simple bunionectomies have higher-than-average failure rates.
The system will come with various plate options and procedure-specific implants with a range of screw diameters to cover multiple foot and ankle procedures.
The news follows another FDA clearance for DePuy Synthes after the agency cleared the company’s TriATLIS thoracolumbar implant system.
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Analysis by GlobalData placed the global orthopaedic market at $47.6bn in 2022. By 2030, the market is predicted to reach $60.2bn.
In April 2023, J&J agreed to pay almost $9bn to settle tens of thousands of lawsuits filed against the company claiming the use of its talcum powder caused cancer. US courts have blocked J&J’s attempted payout by assigning a subsidiary to manage the claims, meaning the lawsuits are still ongoing.
In September, the company underwent a transformation with its main departmental arms changing names and its logo undergoing a facelift, the famous cursive script being replaced with modernised branding.