Smith+Nephew
(NYSE: SNN)
announced today that it received FDA 510(k) clearance for its new Catalystem primary hip system.
The London-based orthopedic giant designed the system to address the evolving demands of primary hip surgery. That includes the increased adoption of anterior approach procedures and the expanding role of ambulatory surgery centers (ASCs). The system also has compatibility with Smith+Nephew’s Cori surgical robotic platform.
Smith+Nephew said in a news release that advances in primary hip arthroplasty include a shift to a shorter, proximally filling stem. This stem offers easier preparation and insertion using the direct anterior approach. That delivers a less invasive procedure that may enable an improved range of motion and faster recovery.
The company built its Catalystem system on its previous stem designs. It developed it using global data sets across femoral morphologies, helping to deliver a precision fit. The system features a triple-taper stem design with uniform proximal loading. Its reduced distal stem geometry and shorter lengths help with the anterior approach but can extend to all approaches.
Smith+Nephew also designed Catalystem with proprietary, patent-pending AccuBroach technology. This delivers reproducibility between broach and implant, giving confidence in predictable and reproducible stem seating.
“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 of 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.”