Smith+Nephew Receives FDA 510(k) for its AETOS Shoulder System

Smith+Nephew has announced that 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-motion1-4 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.

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

Source: Smith+Nephew