Product code KWI
- Device name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3170
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233592 | BioPoly Radial Head Implant | BioPoly, LLC | 2024-03-13 |
| K231188 | ALIGN Radial Head System | Skeletal Dynamics, Inc. | 2023-09-28 |
| K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | 2022-03-18 |
| K212872 | Avenger Radial Head System | In2bones USA, LLC | 2021-12-17 |
| K192754 | Avenger Radial Head System | In2bones USA, LLC | 2020-01-07 |
| K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | 2019-05-17 |
| K172688 | Align Radial Head System | Skeletal Dynamics, LLC | 2017-12-22 |
| K132735 | AXIA RADIAL HEAD SYSTEM | Imds (Innovative MEdical Device Systems) - Leis ME | 2014-01-07 |
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | Acumed, LLC | 2013-09-30 |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | Synthes USA, LLC | 2012-06-19 |
| K092721 | ALIGN RADIAL HEAD SYSTEM | Skeletal Dynamics, LLC | 2010-08-03 |
| K062898 | SBI LATERAL RHEAD IMPLANT | Small Bone Innovations, Inc. | 2006-11-13 |
| K060731 | EVOLVE MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | 2006-04-19 |
| K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2005-08-05 |
| K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | Acumed, LLC | 2004-10-05 |
| K040611 | MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2004-06-04 |
| K032806 | KATALYST RADIAL HEAD IMPLANT | Kinetikos Medical, Inc. | 2004-04-16 |
| K032686 | ASCENSION MODULAR RADIAL HEAD | Ascension Orthopedics, Inc. | 2003-10-22 |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Kapp Surgical Instrument, Inc. | 2003-08-29 |
| K030384 | EVOLVE CERAMIC RADIAL HEAD IMPLANT | Wrightmedicaltechnologyinc | 2003-08-12 |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2002-11-27 |
| K012551 | LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2002-01-30 |
| K011819 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-06-19 |
| K002644 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2000-11-20 |
| K994041 | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS | Tornier, Inc. | 2000-08-31 |
| K001385 | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS | Howmedica Osteonics Corp. | 2000-07-27 |
| K000658 | ERS RADIAL HEAD REPLACEMENT | DePuy Orthopaedics, Inc. | 2000-05-11 |
| K992220 | RADIAL HEAD PROSTHESIS | Smith & Nephew, Inc. | 2000-02-25 |
| K991915 | MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | 1999-09-03 |
| K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM | Implex Corp. | 1999-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10381780065791 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065784 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065876 | Katalyst™ Bipolar Radial Head System | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780065869 | Katalyst™ Bipolar Radial Head System | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780065852 | Katalyst™ Bipolar Radial Head System | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780065845 | Katalyst™ Bipolar Radial Head System | INTEGRA LIFESCIENCES CORPORATION | 2017-10-09 |
| 10381780065838 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065821 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065814 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780065807 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2017-10-09 |
| 10381780236412 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236405 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236399 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236382 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236375 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236368 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236351 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236344 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236337 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236320 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236313 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236306 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236290 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236283 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236276 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236269 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236252 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236245 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780236238 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |
| 10381780235002 | Integra® | Ascension Orthopedics, Inc. | 2016-08-15 |