Smith+Nephew has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its CATALYSTEM Primary Hip System.
The system is designed to meet the evolving needs of primary hip surgery, including the expanding role of ambulatory surgery centres (ASCs) and the growing preference for anterior approach procedures.
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The CATALYSTEM Primary Hip System has been developed using extensive global data sets across femoral morphologies, to ensure a precision fit.
Its triple-taper stem design, which features uniform proximal loading, is complemented by reduced distal stem geometry and shorter lengths, making it an ideal choice for anterior approach surgeries while remaining suitable for all surgical approaches.
Furthermore, the CATALYSTEM Primary Hip System incorporates the patent-pending ACCUBROACH Technology.
The technology is designed to ensure proven reproducibility between implant and broach, thereby providing surgeons with confidence in predictable and reproducible stem seating.
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By GlobalDataOrlando Health’s George Haidukewych contributed to the system’s design.
Haidukewych said: “The design of CATALYSTEM facilitates accurate fit and fill proximally without distal interference. It is ideally suited for the direct anterior approach and caters to the diverse needs of my patients.
“Additionally, the system is delivered in a single modular tray, tailored to my surgical approach. This helps drive efficiencies in facilitating more shelf space and reducing sterilisation costs – perfect for my ASC setting.”
Designed to be compatible with the CORI Surgical System, the CATALYSTEM system is intended to offer precision and efficiency in surgical procedures.
Smith+Nephew Global Orthopaedics president Craig Gaffin said: “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.
“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.”
In April this year, Smith+Nephew launched its RENASYS EDGE Negative Pressure Wound Therapy (NPWT) System in the US.
