Smith+Nephew Gains FDA Clearance for AETOS Stemless Shoulder System

Smith+Nephew, the global medical technology company, announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless).

AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure. It is designed to maximize metaphyseal fixation and stability with an inlay collar, cruciate fins, and porous titanium coating to encourage biological fixation.

Introduced last year, the AETOS Shoulder System delivers an elegant design and an elevated experience through its simplicity, uniformity and flexibility. The new stemless implant expands the AETOS Shoulder System portfolio enabling streamlined convertibility from Stemless to Meta Stem.

“AETOS Stemless represents a significant advancement in shoulder arthroplasty, underscoring our commitment to superior patient outcomes and driving progress in the field of orthopaedic surgery. We are excited to continue unveiling future technologies that will reshape the treatment of shoulder conditions,” said Craig Gaffin, president of global orthopaedics for Smith+Nephew. “With AETOS Stemless, we’re now able to further personalize surgery, providing options that help surgeons give patients the best chance for recovery and a return to living their Life Unlimited.”

Total shoulder arthroplasty is one of the fastest growing segments in Orthopaedics with an estimated 250,000 procedures annually in the US by 2025.

Cleared for use in the United States and approved for use Canada, the AETOS Shoulder System, including AETOS Stemless, is the latest solution in Smith+Nephew’s expanding Upper Extremity portfolio - complementing our market leading Sports Medicine shoulder repair and biologics solutions.

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. The company exist to restore people’s bodies and their self-belief by using technology to take the limits off living.

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