Panels › Orthopedic › Product code KWI · Class 2
Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation 888.3170
1510(k)s in 12 months (34 all time)
0recalls in 12 months (30 all time)
29recalls that name a 510(k)
Top companies in KWI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K260624 | Arthrex Radial Head Replacement System Arthrex, Inc. | KWI |
| Mar 13, 2024 | K233592 | BioPoly Radial Head Implant BioPoly, LLC | KWI |
| Sep 28, 2023 | K231188 | ALIGN Radial Head System Skeletal Dynamics, Inc. | KWI |
| Mar 18, 2022 | K213563 | DePuy Synthes Radial Head Replacement System DePuy Synthes | KWI |
| Dec 17, 2021 | K212872 | Avenger Radial Head System In2bones USA, LLC | KWI |
| Jan 7, 2020 | K192754 | Avenger Radial Head System In2bones USA, LLC | KWI |
| May 17, 2019 | K183618 | Revolution Radial Head Ignite Orthopedics, Inc. | KWI |
| Dec 22, 2017 | K172688 | Align Radial Head System Skeletal Dynamics, LLC | KWI |
| Jan 7, 2014 | K132735 | AXIA RADIAL HEAD SYSTEM Imds (Innovative MEdical Device Systems) - Leis ME | KWI |
| Sep 30, 2013 | K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC Acumed, LLC | KWI |
| Jun 19, 2012 | K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM Synthes USA, LLC | KWI |
| Aug 3, 2010 | K092721 | ALIGN RADIAL HEAD SYSTEM Skeletal Dynamics, LLC | KWI |
| Nov 13, 2006 | K062898 | SBI LATERAL RHEAD IMPLANT Small Bone Innovations, Inc. | KWI |
| Apr 19, 2006 | K060731 | EVOLVE MODULAR RADIAL HEAD Wrightmedicaltechnologyinc | KWI |
| Aug 5, 2005 | K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. | KWI |
| Oct 5, 2004 | K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM Acumed, LLC | KWI |
| Jun 4, 2004 | K040611 | MODULAR RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. | KWI |
| Apr 16, 2004 | K032806 | KATALYST RADIAL HEAD IMPLANT Kinetikos Medical, Inc. | KWI |
| Oct 22, 2003 | K032686 | ASCENSION MODULAR RADIAL HEAD Ascension Orthopedics, Inc. | KWI |
| Aug 29, 2003 | K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT Kapp Surgical Instrument, Inc. | KWI |
| Aug 12, 2003 | K030384 | EVOLVE CERAMIC RADIAL HEAD IMPLANT Wrightmedicaltechnologyinc | KWI |
| Nov 27, 2002 | K023604 | MODIFICATION TO RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Jan 30, 2002 | K012551 | LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE Biomet, Inc. | KWI |
| Jun 19, 2001 | K011819 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Nov 20, 2000 | K002644 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Aug 31, 2000 | K994041 | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS Tornier, Inc. | KWI |
| Jul 27, 2000 | K001385 | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS Howmedica Osteonics Corp. | KWI |
| May 11, 2000 | K000658 | ERS RADIAL HEAD REPLACEMENT DePuy Orthopaedics, Inc. | KWI |
| Feb 25, 2000 | K992220 | RADIAL HEAD PROSTHESIS Smith & Nephew, Inc. | KWI |
| Sep 3, 1999 | K991915 | MODULAR RADIAL HEAD Wrightmedicaltechnologyinc | KWI |
| Jun 1, 1999 | K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM Implex Corp. | KWI |
| Sep 8, 1998 | K982288 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Jul 13, 1995 | K944507 | METALLIC RADIAL HEAD IMPLANTS Wrightmedicaltechnologyinc | KWI |
| Apr 24, 1989 | K885146 | CL UNIVERSAL HIP DEVICE Lima Intl. Corp. | KWI |
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