Smith+Nephew’s Aetos Shoulder System Receives FDA Clearance
Smith+Nephew's Aetos Shoulder System Receives FDA Clearance
Smith+Nephew’s Aetos shoulder system has obtained clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) pathway. This innovative system aims to restore range of motion and alleviate arthritic shoulder pain. The key feature of Aetos is its Meta Stem, which has been meticulously engineered to enhance stability, preserve bone integrity, and maintain the patient’s anatomy. The system is suitable for both anatomic and reverse total shoulder arthroplasty.
Aetos offers several advantages, including a streamlined conversion process and a reduced number of instruments required for primary anatomic and reverse surgeries. This simplifies the surgical procedures and enhances efficiency.
Dr. James Kelly, a renowned shoulder and elbow specialist at California Pacific Orthopaedics in San Francisco, and the design surgeon for the AETOS System, expressed his thoughts to the press. He stated, “The AETOS Shoulder System was developed as an advanced press fit, bone-conserving, convertible humeral stem. The system caters to surgeons who seek maximum flexibility in reconstructing the humerus and glenoid. It provides an efficient and intuitive platform that prioritizes patient outcomes.”
Brad Cannon, the president of Global Orthopaedics for Smith+Nephew, emphasized the significance of receiving FDA clearance for the AETOS Shoulder System. He remarked, “This milestone marks a significant achievement for Smith+Nephew. The development of this platform is the culmination of extensive research and development, demonstrating our commitment to equipping healthcare professionals with the best technology available for their patients. We have full confidence that this platform will advance the standard of care in shoulder surgery and we eagerly anticipate its positive impact on patient outcomes.”
In addition to the Aetos shoulder system, Smith+Nephew recently introduced two other noteworthy advancements. They unveiled RI.KNEE Robotics 2.0, which incorporates personalized planning, and the RI.INSIGHTS data visualization platform. These additions further exemplify the company’s commitment to delivering cutting-edge solutions in the field of orthopedics.