FDA Product Code KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer
Leading manufacturers include Wrightmedicaltechnologyinc, Biomet, Inc. and In2bones USA, LLC.
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
Mar 18, 2022
DePuy Synthes Radial Head Replacement System
DePuy Synthes
Orthopedic
129d
Cleared
Dec 17, 2021
Avenger Radial Head System
In2bones USA, LLC
Orthopedic
99d
Cleared
Jan 07, 2020
Avenger Radial Head System
In2bones USA, LLC
Orthopedic
99d
Cleared
May 17, 2019
Revolution Radial Head
Ignite Orthopedics, Inc.
Orthopedic
142d
Cleared
Apr 19, 2006
EVOLVE MODULAR RADIAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
30d
Cleared
Aug 05, 2005
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
Biomet, Inc.
Orthopedic
70d
Cleared
Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
Biomet, Inc.
Orthopedic
88d
Cleared
Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
Wrightmedicaltechnologyinc
Orthopedic
188d
Cleared
Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
Biomet, Inc.
Orthopedic
176d
Cleared
Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
Howmedica Osteonics Corp.
Orthopedic
86d
Cleared
Feb 25, 2000
RADIAL HEAD PROSTHESIS
Smith & Nephew, Inc.
Orthopedic
239d
Cleared
Sep 03, 1999
MODULAR RADIAL HEAD
Wrightmedicaltechnologyinc
Orthopedic
88d
Cleared
Jul 13, 1995
METALLIC RADIAL HEAD IMPLANTS
Wrightmedicaltechnologyinc
Orthopedic
301d
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.