FDA Product Code KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer
Leading manufacturers include BioPoly, LLC, In2bones USA, LLC and Skeletal Dynamics, Inc..
33
Total
33
Cleared
137d
Avg days
1989
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Prosthesis, Elbow, Hemi-, Radial, Polymer Devices (Product Code KWI)
33 devices
Cleared
Mar 13, 2024
BioPoly Radial Head Implant
BioPoly, LLC
Orthopedic
126d
Cleared
Sep 28, 2023
ALIGN Radial Head System
Skeletal Dynamics, Inc.
Orthopedic
155d
Cleared
Dec 17, 2021
Avenger Radial Head System
In2bones USA, LLC
Orthopedic
99d
About Product Code KWI - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code KWI since 1989, with 33 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
KWI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →