FDA Product Code KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Hip hemiarthroplasty is the standard treatment for femoral neck fractures in elderly patients. FDA product code KWY covers cemented femoral hip hemiarthroplasty prostheses.
These cemented implants replace only the femoral head — leaving the native acetabulum intact — to restore hip mobility and relieve pain following femoral neck fractures without the complexity of total hip replacement in frail patients.
KWY devices are Class II medical devices, regulated under 21 CFR 888.3390 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Waldemar Link GmbH & Co. KG, Depuy Ireland UC and Maxx Orthopedics, Inc..
List of Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented devices (product code KWY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →