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, G21, S.R.L. and Depuy Ireland UC.