Smith & Nephew receives FDA 510(k) clearance for THA system
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Key takeaways:
- Smith & Nephew received FDA 510(k) clearance for the Catalystem primary hip system.
- The system is designed to accommodate different approaches and can be used in the ASC.
Smith & Nephew announced FDA 510(k) clearance for its Catalystem primary hip system for total hip arthroplasty, according to a company press release.
The Catalystem primary hip system is designed to accommodate the adoption of anterior approach THA and procedures performed in ASCs. The system features a triple-taper stem design that is ideal for direct anterior THA procedures but can be applicable for all approaches, according to the release.
“Building on the strong clinical heritage of Polar3, our Catalystem primary hip system represents a significant milestone for Smith & Nephew’s hip business, complementing our current hip portfolio with a primary stem ideal for advanced anterior approaches,” Craig Gaffin, president of global orthopedics for Smith & Nephew, said in the release. “Engineered for precision, confidence and surgical efficiencies, the launch of this new stem combined with our proprietary, market leading Oxinium technology and integration with our robotics platform will help Smith & Nephew continue to enhance patient outcomes in hip surgery.”
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