Best-in-class Just Got Better; Smith+Nephew Announces 510(k) Clearance of New CATALYSTEM™ Primary Hip System

Best-in-class Just Got Better; Smith+Nephew Announces 510(k) Clearance of New CATALYSTEM™ Primary Hip System

Engineered for precision, confidence and efficiency in surgery - and compatible with the CORI◊ Surgical System

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance for its new CATALYSTEM Primary Hip System from the United States Food and Drug Administration. The system is designed to address the evolving demands of primary hip surgery including the increased adoption of anterior approach procedures and the expanding role of Ambulatory Surgery Centers (ASCs).

Advancements in primary hip arthroplasty include a shift to a shorter, proximally filling stem that is easier to prepare and insert using the direct anterior approach – a less invasive procedure that may enable improved range-of-motion and faster recovery for patients.1,2 This segment fits a diverse range of patient anatomies and is rapidly growing at a compound annual growth rate >10%.

Building on the heritage of Smith+Nephew’s clinically successful stem designs,3,4 the CATALYSTEM Primary Hip System was developed using global data sets across femoral morphologies to help deliver a precision fit.5,6 Featuring a triple-taper stem design with uniform proximal loading,7 the reduced distal stem geometry and shorter lengths are ideal for anterior approach but suitable for all approaches.8

“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,” said George Haidukewych MD, Orlando Health, Orlando, Florida and a contributor in the systems design. “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 sterilization costs - perfect for my ASC setting.”

The CATALYSTEM Primary Hip System also utilizes proprietary, patent-pending, ACCUBROACH◊ Technology delivering proven reproducibility between broach and implant giving confidence in predictable and reproducible stem seating.9,10

Don Garbuz, President of the Hip Society, Vancouver, Canada and a contributor in the systems design said, “We wanted to give surgeons confidence in broach to implant relationship; the implant reproducing where the broach was seated. During the design process, we put in a lot of time developing ACCUBROACH Technology with various tooth patterns to ensure we could duplicate excellent axial and rotational stability and validated that the stem sits exactly where we want it. We’re extremely pleased with the outcome.”

“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, said Craig Gaffin, President Global Orthopaedics for Smith+Nephew. “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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