Smith+Nephew announces 510(k) clearance of its AETOS™ Shoulder System for anatomic and reverse shoulder replacement

LONDON, June 12, 2023 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its AETOS Shoulder System.

• Designed to restore patients' range-of-motion^1-4 and help minimize arthritic shoulder pain.
• Features the AETOS Meta Stem - designed to maximize stability, preserve bone, and maintain patient anatomy.^{1, 5-7}
• Indicated for both anatomic and reverse total shoulder arthroplasty.
• Total shoulder arthroplasty is one of the fastest growing segments in Orthopaedics with an estimated 250,000 procedures in the US by 2025.⁸

For healthcare professionals, the AETOS Shoulder System offers a compact yet comprehensive portfolio of solutions that enhance the surgical experience by enabling intraoperative flexibility.^1,5 With fewer steps for conversion^*5 and fewer instruments for primary anatomic and reverse,^*5 the system is designed to simplify the operating room flow.⁵

Dr. James Kelly, shoulder and elbow specialist at California Pacific Orthopaedics in San Francisco and AETOS System design surgeon, commented "The AETOS Shoulder System was designed to be a cutting-edge press fit, bone conserving, convertible humeral stem. The system is designed for surgeons who desire maximum flexibility to reconstruct the humerus and glenoid, using an efficient and intuitive system that helps prioritize patient outcomes." 

"Receiving FDA clearance for the AETOS Shoulder System is a major milestone for Smith+Nephew. This platform is the culmination of years of research and development and represents our commitment to providing healthcare professionals with the best possible technology for their patients. We are confident that this platform will further evolve the standard of care for shoulder surgery and are excited to see the impact it has on patient outcomes," commented Brad Cannon, President Global Orthopaedics for Smith+Nephew.

The AETOS Shoulder System is the latest solution in Smith+Nephew's expanding Upper Extremity portfolio and complements our market leading Sports Medicine shoulder repair and biologics solutions. To learn more please click here.

The AETOS Shoulder System will be showcased this week at the San Diego Shoulder Institute's annual shoulder course in Coronado, CA.

References 

1. Smith+Nephew 2023. AETOS Inlay Design Features. Internal Report. ER-04-0990-0017.
2. Arenas-Miquelez A, Murphy R, Rosa A, Caironi D, Zumstein M. Impact of humeral and glenoid component variations on range of motion in reverse geometry total shoulder arthroplasty. A standardised computer model study. (8214). Swiss Medical Weekly. 2020;150(SUPPL 244):2S.
3. Kalouche I, Sevivas N, Wahegaonker A, Sauzieres P, Katz D, Valenti P. Reverse shoulder arthroplasty: Does reduced medialisation improve radiological and clinical results? Acta Orthopaedica Belgica. 2009;75(2):158-166.
4. Lädermann A, Tay E, Collin P, et al. Effect of critical shoulder angle, glenoid lateralization, and humeral inclination on range of movement in reverse shoulder arthroplasty. Bone Joint Res. 2019;8(8):378-386.
5. Smith+Nephew 2023. AETOS Instruments & Trays. Internal Report. ER-04-0990-0020.
6. Smith+Nephew 2023. AETOS Anatomic Humeral Head Design. Internal Report. ER-04-0990-0019.
7. Harmer L, Throckmorton T, Sperling JW. Total shoulder arthroplasty: are the humeral components getting shorter? Curr Rev Musculoskelet Med. 2016;9(1):17-22.
8. SmartTrak Report, 2023

*Compared to a competitive shoulder system

Smith+Nephew is a portfolio medical technology company 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 19,000 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 franchises 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 $5.2 billion in 2022. 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 Twitter, LinkedIn, Instagram or Facebook.

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading 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: risks related to the impact of Covid, such as the depth and longevity of its impact, government actions and other restrictive measures taken in response, material delays and cancellations of elective procedures, reduced procedure capacity at medical facilities, restricted access for sales representatives to medical facilities, or our ability to execute business continuity plans as a result of Covid; economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers (including, without limitation, as a result of Covid); 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 (including, without limitation, as a result of Covid); competition for qualified personnel; strategic actions, including acquisitions and dispositions, 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/smithnephew-announces-510k-clearance-of-its-aetos-shoulder-system-for-anatomic-and-reverse-shoulder-replacement-301848169.html

SOURCE Smith & Nephew plc