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 G21, S.R.L., Depuy Ireland UC and Maxx Orthopedics, Inc..
FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented Devices (Product Code KWY)
About Product Code KWY - Regulatory Context
510(k) Submission Activity
99 total 510(k) submissions under product code KWY since 1978, with 99 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under KWY have taken an average of 234 days to reach a decision - up from 138 days historically. Manufacturers should account for longer review timelines in current project planning.
KWY devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →