FDA Product Code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
Leading manufacturers include Howmedica Osteonics Corp., Dba Stryker Orthopaedics and Biocomposites, Ltd..
2
Total
2
Cleared
158d
Avg days
2022
Since
List of Prosthesis, Hip, Hemi-, Femoral, Metal devices cleared through 510(k)
2 devices
Cleared
Jun 12, 2025
Synicem Hip Spacer
Biocomposites, Ltd.
Orthopedic
265d
Cleared
Oct 21, 2022
UHR Bipolar Implants, Restoration GAP II Implants
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
51d
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Hip, Hemi-, Femoral, Metal devices (product code KWL). 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 →