Smith+Nephew Expands AETOS Shoulder System with FDA 510(k) Clearance for Stemless Implant

Smith+Nephew has announced that its AETOS Stemless Shoulder Implant has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). This new addition to the AETOS Shoulder System provides an innovative solution for anatomic total shoulder replacement, addressing the growing demand for less invasive procedures with a smaller operating room footprint. The stemless design ensures enhanced metaphyseal fixation and stability, featuring an inlay collar, cruciate fins, and a porous titanium coating that promotes biological fixation.

Introduced last year, the AETOS Shoulder System is known for its simplicity, uniformity, and flexibility, offering surgeons a seamless transition from the stemless option to the Meta Stem design. With the launch of the stemless implant, the system continues to deliver on its promise of providing personalized and effective surgical solutions. “AETOS Stemless marks a key advancement in shoulder arthroplasty, underscoring our commitment to superior patient outcomes and supporting the evolution of orthopaedic surgery,” said Craig Gaffin, President of Global Orthopaedics at Smith+Nephew.

As shoulder arthroplasty becomes one of the fastest-growing segments in orthopaedics, with an estimated 250,000 procedures projected annually in the U.S. by 2025, the AETOS Stemless implant further strengthens Smith+Nephew’s Upper Extremity portfolio. Cleared for use in the U.S. and approved in Canada, the AETOS Shoulder System complements the company’s leading sports medicine and biologics solutions, providing surgeons with a comprehensive set of tools to improve patient outcomes.