Smith & Nephew - FDA 510(k) Cleared Devices

Smith & Nephew, is a medical technology company focused on repair, regeneration, and replacement of soft and hard tissues. The company operates with a manufacturing facility in Memphis, US, and serves approximately 100 countries worldwide.

The company has received 17 FDA 510(k) clearances from 17 total submissions since 2015. Orthopedic devices represent the dominant category, including pelvic and acetabular systems, patella plates, suture anchors, cable systems, external fixators, arthroscopes, and limb lengthening systems. The latest clearance was granted in 2025, confirming active regulatory engagement.

Smith & Nephew's product portfolio spans advanced wound care, orthopedic surgery, arthroscopic procedures, and otorhinolaryngology. The company emphasizes clinical education through Smith+Nephew Academy, offering structured online learning modules, virtual events, and webinars for healthcare professionals.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database.

510(k) submissions have been managed by Smith+Nephew as regulatory consultant.