Smith+Nephew Expands AETOS Shoulder System

The U.S. Food and Drug Administration (FDA) has granted Smith+Nephew 510(k) clearance for a stemless anatomic total shoulder for the company’s AETOS Shoulder System (AETOS Stemless).

AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint, enabling 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 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 orthopedic 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 orthopedics, with industry estimates predicting 250,000 U.S. procedures to be completed annually 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 its Sports Medicine shoulder repair and biologics solutions.

Smith+Nephew is a portfolio medical technology business focused on soft and hard tissue repair, regeneration, and replacement. The company’s 18,000 employees make a difference to patients’ lives through a diversified product portfolio, and the invention and application of new technologies across three global business units—Orthopaedics, Sports Medicine & ENT, and Advanced Wound Management.

Founded in Hull, United Kingdom, in 1856, Smith+Nephew now operates in more than 100 countries, and generated $5.5 billion in annual sales last year. Smith+Nephew is a constituent of the FTSE100.

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