Zimmer, Inc. - FDA 510(k) Cleared Devices

Zimmer, Inc. is a leading orthopedic medical device manufacturer based in Warsaw, US. The company specializes in innovative surgical implants and trauma solutions.

Zimmer, Inc. maintains a strong FDA 510(k) regulatory record with 356 cleared devices from 377 total submissions since 1976. Orthopedic devices represent approximately 90% of the company's submission portfolio. The company remains actively engaged in product development, with the latest FDA 510(k) clearance in 2026.

Recent cleared devices reflect the company's focus on joint reconstruction and trauma fixation. Notable product lines include personalized knee systems, hip implants, shoulder systems, and femoral nailing systems. The portfolio also encompasses revision solutions and stemless shoulder technologies.

Explore the complete regulatory history, including device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Zimmer GmbH, Zimmer Biomet and Zimmer, Inc./ Zimmer, K.K..