The AETOS Shoulder System is part of the company’s upper extremity portfolio. Credit: Smith and Nephew / PRNewswire.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Smith+Nephew’s AETOS Shoulder System.

As part of the company’s upper extremity portfolio, the new system is intended for both anatomic and reverse total shoulder arthroplasty.

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It also complements the company’s sports medicine shoulder repair and biologics solutions.

AETOS System design surgeon Dr James Kelly said: “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 prioritise patient outcomes.”

The system has been developed for restoring patients’ range of motion and reduction of arthritic shoulder pain.

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It comes with the AETOS Meta Stem, which helps maintain patient anatomy, maximise stability and preserve bone.

Designed to simplify the operating room flow, the system provides a compact and comprehensive portfolio of solutions that improve the surgical experience by facilitating intraoperative flexibility.

Smith+Nephew global orthopaedics president Brad Cannon said: “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.”

Last month, Smith+Nephew secured an Innovative Technology contract from Vizient to distribute its PICO single-use negative pressure wound therapy (sNPWT) system, a portable, easy-to-use, canister-free system equipped with the company’s soft port technology.