Smith+Nephew expands AETOS™ Shoulder System with new stemless option for anatomic shoulder arthroplasty
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.
Smith+Nephew (NYSE:SNN) ha ricevuto l'autorizzazione FDA 510(k) per il suo AETOS Stemless, un nuovo impianto totale per spalla anatomico senza gambo. Questa aggiunta espande il portafoglio del Sistema Spalla AETOS, introdotto lo scorso anno. Il dispositivo presenta un colletto in inlay, pinne crociate e un rivestimento in titanio poroso progettato per favorire la fissazione biologica e massimizzare la stabilità.
L'AETOS Stemless consente una conversione semplificata da Stemless a Meta Stem, offrendo ai chirurghi maggiore flessibilità nella personalizzazione dei trattamenti. Il sistema è autorizzato per l'uso negli Stati Uniti e approvato in Canada, completando le soluzioni di riparazione della spalla e di biologici di Smith+Nephew. Si prevede che l'arto spalla totale raggiunga 250.000 interventi annuali negli Stati Uniti entro il 2025.
Smith+Nephew (NYSE:SNN) ha recibido la aprobación 510(k) de la FDA para su AETOS Stemless, un nuevo implante anatómico total de hombro sin vástago. Esta adición amplía la cartera del Sistema de Hombro AETOS, que se introdujo el año pasado. El dispositivo cuenta con un collarin en inlay, aletas cruzadas y un recubrimiento de titanio poroso diseñado para fomentar la fijación biológica y maximizar la estabilidad.
El AETOS Stemless permite una conversión simplificada de Stemless a Meta Stem, ofreciendo a los cirujanos mayor flexibilidad en la personalización de los tratamientos. El sistema está autorizado para su uso en Estados Unidos y aprobado en Canadá, complementando las soluciones de reparación de hombro y biológicos de Smith+Nephew. Se proyecta que la artroplastia total de hombro alcanzará 250,000 procedimientos anuales en EE. UU. para 2025.
Smith+Nephew (NYSE:SNN)는 새로운 스템리스 해부학적 총 어깨 임플란트인 AETOS Stemless에 대해 FDA 510(k) 승인을 받았습니다. 이 추가는 지난해 도입된 AETOS 어깨 시스템 포트폴리오를 확장합니다. 이 장치는 생물학적 고정을 촉진하고 안정성을 극대화하기 위해 설계된 인레이 칼라, 십자 핀 및 다공성 티타늄 코팅을 특징으로 합니다.
AETOS Stemless는 스템리스에서 메타 스템으로의 간소화된 전환을 가능하게 하여 외과 의사에게 치료를 개인화할 수 있는 더 많은 유연성을 제공합니다. 이 시스템은 미국에서 사용이 허가되었으며 캐나다에서 승인되어 Smith+Nephew의 스포츠 의학 어깨 수리 및 생물학적 솔루션을 보완합니다. 총 어깨 관절 성형수술은 2025년까지 미국에서 연간 250,000건의 시술에 도달할 것으로 예상됩니다.
Smith+Nephew (NYSE:SNN) a reçu l'autorisation FDA 510(k) pour son AETOS Stemless, un nouvel implant total d'épaule anatomique sans tige. Cet ajout élargit le portefeuille du Système d'Épaule AETOS, qui a été introduit l'année dernière. Le dispositif présente un col en inlay, des ailettes croisées et un revêtement en titane poreux conçu pour favoriser la fixation biologique et maximiser la stabilité.
L'AETOS Stemless permet une convertibilité simplifiée de Stemless à Meta Stem, offrant aux chirurgiens plus de flexibilité dans la personnalisation des traitements. Le système est autorisé aux États-Unis et approuvé au Canada, complétant les solutions de réparation de l'épaule et de produits biologiques de Smith+Nephew. L'arthroplastie totale de l'épaule devrait atteindre 250 000 interventions annuelles aux États-Unis d'ici 2025.
Smith+Nephew (NYSE:SNN) hat die FDA-Zulassung 510(k) für sein AETOS Stemless, ein neues anatomisches Total-Schulterimplantat ohne Schaft, erhalten. Diese Erweiterung ergänzt das Portfolio des AETOS-Schulter-Systems, das im vergangenen Jahr eingeführt wurde. Das Gerät verfügt über einen Einlagekragen, kreuzförmige Flossen und eine poröse Titanbeschichtung, die darauf ausgelegt ist, biologische Verankerung zu fördern und die Stabilität zu maximieren.
Das AETOS Stemless ermöglicht eine vereinfachte Umstellung von Stemless auf Meta Stem, wodurch Chirurgen mehr Flexibilität bei der Personalisierung von Behandlungen erhalten. Das System ist für die Verwendung in den Vereinigten Staaten genehmigt und in Kanada zugelassen und ergänzt die Lösungen von Smith+Nephew zur Reparatur der Schulter und zu biologischen Produkten. Es wird prognostiziert, dass die totale Schulterarthroplastik bis 2025 jährlich 250.000 Eingriffe in den USA erreichen wird.
- 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
- None.
Insights
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.
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
- Smith+Nephew 2023. AETOS Instruments & Trays. Internal Report. ER-04-0990-0020 REV B.
- Smith+Nephew 2023. AETOS Inlay Design Features. Internal Report. ER-04-0990-0017 REV C.
- Smith+Nephew 2024. AETOS Short Stem Stability Report. Internal Report. ER-04-0990-0008 REV AC
- Carpenter SR, Urits I, Murthi AM. Porous metals and alternate bearing surfaces in shoulder arthroplasty. Curr Rev Musculoskelet Med. 2016;9(1):59-66
- 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.
- 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
- 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
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.
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FAQ
What is the significance of FDA 510(k) clearance for SNN's AETOS Stemless shoulder implant?
What are the key features of SNN's new AETOS Stemless shoulder implant?
What is the market potential for SNN's shoulder arthroplasty products in the US?
In which countries is SNN's AETOS Shoulder System currently approved?
