FDA Clears Smith+Nephew’s CATALYSTEM Primary Hip System

Smith+Nephew has received U.S. Food and Drug Administration 510(k) clearance for its new CATALYSTEM Primary Hip System, a product designed to address the evolving demands of primary hip surgery—particularly 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 growing more than 10% annually.

“Building on the 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 OXINIUM Technology and integration with our robotics platform will help Smith+Nephew continue to enhance patient outcomes in hip surgery.”

“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,” stated George Haidukewych M.D., of Orlando Health (Orlando, Fla.) and a contributor in CATALYSTEM’s 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 uses proprietary, patent-pending, ACCUBROACH Technology to deliver proven reproducibility between broach and implant giving confidence in predictable and reproducible stem seating.^9,10

“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,” noted Don Garbuz, president of the Hip Society in Vancouver, Canada, and a contributor in the system’s design. 

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. It employs 18,000 workers and develops new technologies across three global business units: Orthopaedics, Sports Medicine and ENT, and Advanced Wound Management. Founded in Hull, U.K., in 1856, Smith+Nephew operates in more than 100 countries, and generated $5.5 billion in 2023 sales. Smith+Nephew is a constituent of the FTSE100. 

References
¹ Kyriakopoulos G, Poultsides L, Christofilopoulos P. Total hip arthroplasty through an anterior approach: The pros and cons. EFORT Open Rev. 2018 Nov 1;3(11):574-583.
² Ang JJM, Onggo JR, Stokes CM, Ambikaipalan A. Comparing direct anterior approach versus posterior approach or lateral approach in total hip arthroplasty: a systematic review and meta-analysis. Eur J Orthop Surg Traumatol. 2023 Oct;33(7):2773-2792
³ Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem: Synergy. Internal Report. 10143364 REV A
⁴ Smith + Nephew 2024. CATALYSTEM Comparison to legacy stem: POLARSTEM. Internal Report. 10143423 REV A
⁵ Smith + Nephew 2024 CATALYSTEM Summary of Global Evaluations. Internal Report. 10143591
⁶ Smith + Nephew 2024. Three-dimensional assessment stem fit and restoration of natural biomechanics in a globally diverse population of femoral CT scans. Internal Report. TM-24-034
⁷ Smith + Nephew 2024. Finite Element Analysis of the CATALYSTEM Hip Stem Design. Internal Report. OR-24-025
⁸ Smith + Nephew 2024. Surgeon Feedback on the CATALYSTEM Total Hip System. Internal Report.  CSD.REC.24.001
⁹ Smith + Nephew 2024. Cadaveric study of the repeatability of CATALYSTEM broach and femoral stem seating level. Internal Report. 10144794
¹⁰ Smith + Nephew 2024. CATALYSTEM Accubroach Femur to Bone Interaction Design Rationale. Internal Report. 10142827