FDA Product Code KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Leading manufacturers include Depuy Ireland UC and Medacta International S.A..
FDA 510(k) Cleared Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer Devices (Product Code KWZ)
About Product Code KWZ - Regulatory Context
510(k) Submission Activity
34 total 510(k) submissions under product code KWZ since 1981, with 34 receiving FDA clearance (average review time: 121 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under KWZ have taken an average of 434 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
KWZ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →