KWI · Class II · 21 CFR 888.3170

FDA Product Code KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

Leading manufacturers include Wrightmedicaltechnologyinc, Avanta Orthopaedics, Inc. and Biomet, Inc..

34
Total
34
Cleared
137d
Avg days
1989
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 154d avg (recent)

FDA 510(k) Cleared Prosthesis, Elbow, Hemi-, Radial, Polymer Devices (Product Code KWI)

34 devices
1–24 of 34
Cleared Jul 30, 2026
Arthrex Radial Head Replacement System
K260624
Arthrex, Inc.
Orthopedic · 154d
Cleared Mar 13, 2024
BioPoly Radial Head Implant
K233592
BioPoly, LLC
Orthopedic · 126d
Cleared Sep 28, 2023
ALIGN Radial Head System
K231188
Skeletal Dynamics, Inc.
Orthopedic · 155d
Cleared Mar 18, 2022
DePuy Synthes Radial Head Replacement System
K213563
DePuy Synthes
Orthopedic · 129d
Cleared Dec 17, 2021
Avenger Radial Head System
K212872
In2bones USA, LLC
Orthopedic · 99d
Cleared Jan 07, 2020
Avenger Radial Head System
K192754
In2bones USA, LLC
Orthopedic · 99d
Cleared May 17, 2019
Revolution Radial Head
K183618
Ignite Orthopedics, Inc.
Orthopedic · 142d
Cleared Dec 22, 2017
Align Radial Head System
K172688
Skeletal Dynamics, LLC
Orthopedic · 107d
Cleared Jan 07, 2014
AXIA RADIAL HEAD SYSTEM
K132735
Imds (Innovative MEdical Device Systems) - Leis ME
Orthopedic · 126d
Cleared Sep 30, 2013
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
K131845
Acumed, LLC
Orthopedic · 101d
Cleared Jun 19, 2012
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM
K112030
Synthes (Usa), LLC
Orthopedic · 340d
Cleared Aug 03, 2010
ALIGN RADIAL HEAD SYSTEM
K092721
Skeletal Dynamics, LLC
Orthopedic · 333d
Cleared Nov 13, 2006
SBI LATERAL RHEAD IMPLANT
K062898
Small Bone Innovations, Inc.
Orthopedic · 47d
Cleared Apr 19, 2006
EVOLVE MODULAR RADIAL HEAD
K060731
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Aug 05, 2005
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385
Biomet, Inc.
Orthopedic · 70d
Cleared Oct 05, 2004
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858
Acumed, LLC
Orthopedic · 88d
Cleared Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611
Biomet, Inc.
Orthopedic · 88d
Cleared Apr 16, 2004
KATALYST RADIAL HEAD IMPLANT
K032806
Kinetikos Medical, Inc.
Orthopedic · 220d
Cleared Oct 22, 2003
ASCENSION MODULAR RADIAL HEAD
K032686
Ascension Orthopedics, Inc.
Orthopedic · 54d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Nov 27, 2002
MODIFICATION TO RADIAL HEAD IMPLANT
K023604
Avanta Orthopaedics, Inc.
Orthopedic · 30d
Cleared Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551
Biomet, Inc.
Orthopedic · 176d
Cleared Jun 19, 2001
RADIAL HEAD IMPLANT
K011819
Avanta Orthopaedics, Inc.
Orthopedic · 8d
Cleared Nov 20, 2000
RADIAL HEAD IMPLANT
K002644
Avanta Orthopaedics, Inc.
Orthopedic · 88d

About Product Code KWI - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code KWI since 1989, with 34 receiving FDA clearance (average review time: 137 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - KWI Product Code

FDA review times for KWI submissions have been consistent, averaging 154 days recently vs 137 days historically.

KWI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →