British medical equipment manufacturer Smith+Nephew has received the US Food and Drug Administration (FDA) 510(k) approval for its new Catalystem primary hip system.
The system is designed to meet the growing demands of primary hip surgery, including the adoption of anterior approach procedures and the role of Ambulatory Surgery Centers (ASCs).
Smith+Nephew developed the Catalystem Primary Hip System building on its successful stem designs, using global data sets across femoral morphologies to help provide a precision fit.
The system features a triple-taper stem design with uniform proximal loading, reduced distal stem geometry and shorter lengths, suitable not only for anterior but for all approaches.
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.”
According to the company, primary hip arthroplasty is evolving to include a shorter, proximally filling stem that is easier to prepare and insert using the direct anterior approach.
The Catalystem Primary Hip System optimises hip arthroplasty performance with unique patent pending Accubroach Technology, ensuring reproducibility between broach and implant.
It is the only cementless stem featuring Oxinium Technology, which combines the durability of metal, the wear resistance of ceramic, and superior corrosion resistance compared to both.
With more than 20 years of clinical use, the Oxinium technology has been shown to minimise taper corrosion in total joint arthroplasty.
In addition, the combination of unique Oxinium Oxidized Zirconium heads with highly cross-linked polyethylene (XLPE) liner resulted in the lowest revision rates, said Smith+Nephew.
Hip Society, Vancouver, Canada, president and a contributor in the system’s design, Don Garbuz said: 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.”
