Medical Device Manufacturer · US , Malwah , NJ

Howmedica Osteonics Corp., Dba Stryker Orthopaedics - FDA 510(k) Clea...

31 submissions · 31 cleared · Since 2010

Total

Cleared

Denied

Howmedica Osteonics Corp., Dba Stryker Orthopaedics, is a medical device manufacturer based in Malwah, US. The company operates as part of Stryker, a global medical technology leader.

The company has received 31 FDA 510(k) clearances from 31 total submissions since its first clearance in 2010. 97% of submissions focus on Orthopedic devices, including joint replacement systems, knee implants, and hip components. The latest clearance in 2026 demonstrates continued regulatory activity and product innovation.

Recent cleared devices include the Triathlon® Total Knee System with multiple bearing inserts and femoral components, Triathlon® Hinge Knee System, and ceramic femoral heads for hip reconstruction. The company also maintains labeling updates and modular replacement systems for orthopedic surgeons.

Explore the complete list of device names, product codes, and clearance dates to review the company's full regulatory history.

510(k) submissions have been managed by Howmedica Osteonics Corp (Dba Stryker Orthopaedics) as regulatory consultant.

FDA 510(k) Regulatory Record - Howmedica Osteonics Corp., Dba Stryker Orthopaedics

31 devices

1-12 of 31