Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc. - FDA 510(k) Cleared Devices

530 submissions · 517 cleared · Since 1980

Recent clearances: AETOS Shoulder System - CONCELOC Glenoids, AETOS Shoulder System Meta Humeral Prosthesis Size 0, AETOS Shoulder System Stemless Humeral Prosthesis

Official Website

530

Total

517

Cleared

Denied

Smith & Nephew, Inc. is a medical technology company focused on repair, regeneration, and replacement of soft and hard tissues. The company operates with a manufacturing facility in McHenry, US.

Smith & Nephew has established a significant regulatory track record with the FDA. The company has received 517 FDA 510(k) clearances from 530 total submissions since 1980. Orthopedic devices represent the dominant category, accounting for 71% of submissions. The company remains active, with the latest clearance in 2025.

Recent cleared devices reflect a strong focus on orthopedic surgical solutions, including shoulder prosthesis systems, knee replacement systems, suture anchors, and femoral stems. The company also develops products for wound care management and sports medicine applications.

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

Regulatory submissions have been managed by Kema Quality B.V. and Smith+Nephew, Inc..

Smith & Nephew, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.