Best-in-class just got better; Smith+Nephew announces 510(k) clearance of new CATALYSTEM™ Primary Hip System

Rhea-AI Summary

Smith+Nephew (NYSE:SNN) has received 510(k) clearance for its new CATALYSTEM Primary Hip System from the FDA. This system is designed to meet the evolving demands of primary hip surgery, including the increased adoption of anterior approach procedures and the expanding role of Ambulatory Surgery Centers (ASCs).

Key features of the CATALYSTEM system include:

• A triple-taper stem design with uniform proximal loading
• Reduced distal stem geometry and shorter lengths
• Proprietary ACCUBROACH Technology for reproducibility between broach and implant
• Compatibility with the CORI Surgical System

The system aims to provide precision fit, confidence in stem seating, and surgical efficiencies, making it suitable for diverse patient anatomies and various surgical approaches.

Positive

• Received 510(k) clearance from FDA for CATALYSTEM Primary Hip System
• Designed for anterior approach procedures and Ambulatory Surgery Centers
• Features ACCUBROACH Technology for reproducible stem seating
• Compatible with CORI Surgical System
• Addresses rapidly growing market segment with >10% CAGR

Negative

• None.

Medical Research Analyst

Smith+Nephew's receipt of the FDA's 510(k) clearance for the CATALYSTEM™ Primary Hip System is a noteworthy development in the medical technology sector. The system is tailored for the growing market of primary hip surgeries, particularly benefiting from the increased adoption of the anterior approach. This less invasive procedure can potentially offer faster patient recovery and improved range of motion.

The CATALYSTEM’s design focuses on precision fit and ease of insertion, which can significantly reduce surgery times and improve outcomes. Its triple-taper stem and uniform proximal loading, combined with a reduced distal stem, make it suitable for diverse surgical approaches. This versatility is a strong selling point given the rising demand for anterior approach procedures.

Moreover, the integration of proprietary ACCUBROACH Technology enhances the system’s reproducibility and stability. These technological advancements are essential for ensuring consistent results across varying patient anatomies. Overall, the clearance can be seen as a positive stride in Smith+Nephew's orthopaedic portfolio, aiming to enhance patient outcomes while also supporting operational efficiency in surgical settings.

Market Research Analyst

From a market perspective, the FDA's 510(k) clearance for the CATALYSTEM™ Primary Hip System positions Smith+Nephew to capitalize on the growing hip replacement market, which is expanding at a compound annual growth rate of over 10%. This growth is driven by an aging population and increasing preference for minimally invasive surgical procedures.

The system’s compatibility with the CORI◊ Surgical System and its efficiency in ASCs (Ambulatory Surgery Centers) enhance its market appeal. ASCs are becoming more popular due to lower costs and improved patient convenience compared to traditional hospital settings. The single modular tray design reduces sterilization costs and saves shelf space, which can be significant advantages for ASCs looking to optimize their operations.

Smith+Nephew’s strong clinical heritage and integration of advanced technologies not only bolster the company's competitive edge but also reinforce confidence among surgeons. This combination of innovation and market alignment suggests a promising impact on Smith+Nephew's market share in the orthopaedic sector.

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.”

To learn more about Smith+Nephew’s new CATALYSTEM Primary Hip System for total hip arthroplasty, please visit https://www.smith-nephew.com/en/health-care-professionals/products/orthopaedics/catalystem.

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Enquiries

Media
Dave Snyder          +1 (978) 749-1440 
Smith+Nephew     

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

This material is provided for informational purposes only and is not intended to serve as medical advice.  It is the responsibility of operating physicians to determine and utilise the appropriate products and techniques according to their own clinical judgment for each of their patients. The clinician testimonials set out in this material represent the individual clinician’s own opinions, findings, beliefs, and/or experiences.  Individual results will vary.  he clinicians featured were involved in the development of CATALYSTEM and were compensated by Smith+Nephew for their time. To review the information needed to understand and use CATALYSTEM safely and effectively, including indications for use, contraindications, effects, precautions, and warnings, please consult the product’s applicable Instructions for Use (IFU) prior to use. The information presented in this material may not be appropriate for all markets. Products featured may not be available due to regulatory and/or medical practices in individual markets. Please contact your Smith+Nephew representative if you have questions about availability of Smith+Nephew products in your area.

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people’s bodies and their self-belief by using technology to take the limits off living. We call this purpose ‘Life Unlimited’. Our 18,000 employees deliver this mission every day, making a difference to patients’ lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.5 billion in 2023. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on X, LinkedIn, Instagram or Facebook.

Forward-looking Statements

 This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC’s website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.

^◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.

FAQ

What is the CATALYSTEM Primary Hip System by Smith+Nephew (SNN)?

The CATALYSTEM Primary Hip System is a new hip implant system by Smith+Nephew that received 510(k) clearance from the FDA. It's designed for primary hip surgery, featuring a triple-taper stem design and ACCUBROACH Technology for precise fit and reproducible stem seating.

How does the CATALYSTEM system benefit anterior approach hip surgeries?

The CATALYSTEM system benefits anterior approach surgeries with its reduced distal stem geometry and shorter lengths, making it easier to prepare and insert. This design may enable improved range-of-motion and faster recovery for patients undergoing less invasive procedures.

Is the CATALYSTEM Primary Hip System compatible with Smith+Nephew's (SNN) robotic platform?

Yes, the CATALYSTEM Primary Hip System is compatible with Smith+Nephew's CORI Surgical System, their robotic platform for orthopedic surgeries.

What is the ACCUBROACH Technology in Smith+Nephew's (SNN) CATALYSTEM system?

ACCUBROACH Technology is a proprietary, patent-pending feature of the CATALYSTEM system that delivers proven reproducibility between broach and implant. It gives surgeons confidence in predictable and reproducible stem seating during hip replacement procedures.