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Smith+Nephew
(NYSE: SNN)
announced today that it received FDA 510(k) clearance for its Aetos shoulder system.
London-based Smith+Nephew designed Aetos to restore patients’ range of motion and help minimize arthritic shoulder pain. The system features the Aetos Meta Stem designed for maximizing stability, preserving bone and maintaining patient anatomy.
Aetos adds to the company’s upper extremity portfolio. It complements S+N’s sports medicine shoulder repair and biologics products and services, according to the company.
Smith+Nephew said the FDA clearance covers indications for both anatomic and reverse total shoulder arthroplasty. Company officials believe Aetos offers a compact yet comprehensive portfolio of solutions that enhance the surgical experience. According to the company, it requires fewer steps for conversion and fewer instruments for primary anatomic and reverse arthroplasty. This enables intraoperative flexibility and simplifies the operating room flow, Smith+Nephew said.
Dr. James Kelly, the Aetos system design surgeon, called it a cutting-edge press fit, bone-conserving, convertible humeral stem. He added that surgeons can utilize this “efficient and intuitive system” to prioritize patient outcomes. Kelly serves as a shoulder and elbow specialist at California Pacific Orthopaedics in San Francisco.
“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,” said Brad Cannon, president of global orthopedics for Smith+Nephew. “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.”
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