Zimmer Biomet’s Cementless Knee Device Gains FDA Approval

Zimmer Biomet has announced that its revolutionary Oxford cementless partial knee replacement device has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). With previous success in Europe, where it boasts a 60% market share, this innovative device is poised to make a significant impact in the U.S. medical technology landscape, potentially shifting trends in ambulatory surgical center (ASC) procedures and offering new growth prospects for the company.

The Oxford device distinguishes itself from traditional knee replacements by eliminating reliance on cement; instead, it uses natural bone growth for stabilization. This innovation could lead to longer-lasting, more natural knee function. A U.K. study involving over 33,000 recipients has already validated its effectiveness. Zimmer Biomet’s CEO, Tornos, highlighted the anticipation surrounding the U.S. launch, especially with the growing emphasis on ASC procedures. He emphasized at a recent Morgan Stanley event that this product could become one of the top three growth drivers for knee surgeries in the U.S. Furthermore, Zimmer Biomet is committed to providing FDA-mandated training to ensure the safe and effective use of the device, focusing on the unique surgical technique and patient selection criteria.

With the FDA’s green light, Zimmer Biomet is set to introduce the Oxford cementless knee device to the U.S. market, potentially revolutionizing knee replacement treatments. As the company gears up for the mid-2025 launch, this device will likely join the ranks of Zimmer Biomet’s most significant growth drivers, alongside technologies like the Rosa Shoulder surgical robot and the Persona IQ smart knee implant.

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