FDA Product Code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
Leading manufacturers include Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Heraeus Medical GmbH and Biocomposites, Ltd..
FDA 510(k) Cleared Prosthesis, Hip, Hemi-, Femoral, Metal Devices (Product Code KWL)
About Product Code KWL - Regulatory Context
510(k) Submission Activity
106 total 510(k) submissions under product code KWL since 1979, with 106 receiving FDA clearance (average review time: 110 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for KWL submissions have been consistent, averaging 103 days recently vs 110 days historically.
KWL devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →