Smith+Nephew expands AETOS™ Shoulder System with new stemless option for anatomic shoulder arthroplasty

Rhea-AI Summary

Smith+Nephew (NYSE:SNN) has received FDA 510(k) clearance for its AETOS Stemless, a new stemless anatomic total shoulder implant. This addition expands the AETOS Shoulder System portfolio, which was introduced last year. The device features an inlay collar, cruciate fins, and porous titanium coating designed to encourage biological fixation and maximize stability.

The AETOS Stemless allows for streamlined convertibility from Stemless to Meta Stem, offering surgeons more flexibility in personalizing treatments. The system is cleared for use in the United States and approved in Canada, complementing Smith+Nephew's Sports Medicine shoulder repair and biologics solutions. Total shoulder arthroplasty is projected to reach 250,000 procedures annually in the US by 2025.

Positive

• FDA 510(k) clearance received for new AETOS Stemless shoulder implant
• Expands product portfolio in fast-growing shoulder arthroplasty market
• Market opportunity of 250,000 annual procedures in US by 2025

Negative

• None.

Insights

Medical Device Analyst

The FDA clearance for AETOS Stemless represents a strategic expansion in Smith+Nephew's shoulder arthroplasty portfolio. The timing is particularly advantageous given the projected 250,000 annual procedures in the US by 2025, positioning SNN to capture a larger share of this rapidly growing market. The stemless design's key features - inlay collar, cruciate fins and porous titanium coating - address critical clinical needs while potentially reducing surgical complexity and inventory management costs. This product launch strengthens SNN's competitive position against major players in the shoulder arthroplasty space, while the system's convertibility from Stemless to Meta Stem offers valuable surgical flexibility that could drive adoption among surgeons.

Market Research Analyst

The shoulder arthroplasty segment represents one of the fastest-growing opportunities in orthopedics. This product launch strategically positions SNN to capitalize on this growth trajectory while complementing their existing sports medicine and biologics portfolio. The streamlined design and reduced operating room footprint could translate to improved hospital economics, a important selling point in today's cost-conscious healthcare environment. The expansion also demonstrates SNN's commitment to innovation in high-growth segments, which could positively impact investor sentiment. However, success will depend on surgeon adoption rates and the company's ability to effectively compete with established players in this space.

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless). 

AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure.¹ It is designed to maximize metaphyseal fixation and stability with an inlay collar, cruciate fins, and porous titanium coating to encourage biological fixation.^2-6

Introduced last year, the AETOS Shoulder System delivers an elegant design and an elevated experience through its simplicity, uniformity and flexibility. The new stemless implant expands the AETOS Shoulder System portfolio enabling streamlined convertibility from Stemless to Meta Stem.^1-3

“AETOS Stemless represents a significant advancement in shoulder arthroplasty, underscoring our commitment to superior patient outcomes and driving progress in the field of orthopaedic surgery. We are excited to continue unveiling future technologies that will reshape the treatment of shoulder conditions,” said Craig Gaffin, President of Global Orthopaedics for Smith+Nephew. “With AETOS Stemless, we’re now able to further personalize surgery, providing options that help surgeons give patients the best chance for recovery and a return to living their Life Unlimited.”

Total shoulder arthroplasty is one of the fastest growing segments in Orthopaedics with an estimated 250,000 procedures annually in the US by 2025.⁷

Cleared for use in the United States and approved for use in Canada, the AETOS Shoulder System, including AETOS Stemless, is the latest solution in Smith+Nephew’s expanding Upper Extremity portfolio - complementing our market leading Sports Medicine shoulder repair and biologics solutions. To learn more, please visit: https://www.smith-nephew.com/en-us/health-care-professionals/products/orthopaedics/aetos-shoulder-system

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Enquiries 

Dave Snyder         +1 (978) 749-1440 
Smith+Nephew      david.snyder@smith-nephew.com

References

1. Smith+Nephew 2023. AETOS Instruments & Trays. Internal Report. ER-04-0990-0020 REV B.
2. Smith+Nephew 2023. AETOS Inlay Design Features. Internal Report. ER-04-0990-0017 REV C.
3. Smith+Nephew 2024. AETOS Short Stem Stability Report. Internal Report. ER-04-0990-0008 REV AC
4. Carpenter SR, Urits I, Murthi AM. Porous metals and alternate bearing surfaces in shoulder arthroplasty. Curr Rev Musculoskelet Med. 2016;9(1):59-66
5. Godenèche A, Garret J, Barth J, Michelet A, Geais L. Comparison of revision rates and radiographic observations of long and short, uncoated and coated humeral stem designs in total shoulder arthroplasty. EFORT Open Rev. 2019;4(2):70-76.
6. Morwood MP, Johnston PS, Garrigues GE. Proximal ingrowth coating decreases risk of loosening following uncemented shoulder arthroplasty using mini-stem humeral components and lesser tuberosity osteotomy. Journal of Shoulder and Elbow Surgery. 2017;26(7):1246-1252
7. SmartTrak Report, 2023

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 significance of FDA 510(k) clearance for SNN's AETOS Stemless shoulder implant?

The FDA 510(k) clearance allows Smith+Nephew to market and sell the AETOS Stemless shoulder implant in the United States, expanding their shoulder arthroplasty portfolio and addressing growing market demand.

What are the key features of SNN's new AETOS Stemless shoulder implant?

The AETOS Stemless features an inlay collar, cruciate fins, and porous titanium coating designed to maximize metaphyseal fixation and encourage biological fixation, with a small operating room footprint.

What is the market potential for SNN's shoulder arthroplasty products in the US?

Total shoulder arthroplasty is expected to reach 250,000 procedures annually in the US by 2025, representing a significant market opportunity for Smith+Nephew's AETOS system.

In which countries is SNN's AETOS Shoulder System currently approved?

The AETOS Shoulder System, including the new Stemless option, is currently cleared for use in the United States and approved for use in Canada.