FDA Product Code
FDA Product Code KWI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3170
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260624 | Arthrex Radial Head Replacement System | Arthrex, Inc. | 2026-07-30 | Traditional | PDF ↗ |
| K233592 | BioPoly Radial Head Implant | BioPoly, LLC | 2024-03-13 | Traditional | PDF ↗ |
| K231188 | ALIGN Radial Head System | Skeletal Dynamics, Inc. | 2023-09-28 | Traditional | PDF ↗ |
| K213563 | DePuy Synthes Radial Head Replacement System | DePuy Synthes | 2022-03-18 | Traditional | PDF ↗ |
| K212872 | Avenger Radial Head System | In2bones USA, LLC | 2021-12-17 | Traditional | PDF ↗ |
| K192754 | Avenger Radial Head System | In2bones USA, LLC | 2020-01-07 | Traditional | PDF ↗ |
| K183618 | Revolution Radial Head | Ignite Orthopedics, Inc. | 2019-05-17 | Traditional | PDF ↗ |
| K172688 | Align Radial Head System | Skeletal Dynamics, LLC | 2017-12-22 | Special | PDF ↗ |
| K132735 | AXIA RADIAL HEAD SYSTEM | Imds (Innovative MEdical Device Systems) - Leis ME | 2014-01-07 | Traditional | PDF ↗ |
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | Acumed, LLC | 2013-09-30 | Traditional | PDF ↗ |
| K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | Synthes USA, LLC | 2012-06-19 | Traditional | PDF ↗ |
| K092721 | ALIGN RADIAL HEAD SYSTEM | Skeletal Dynamics, LLC | 2010-08-03 | Traditional | PDF ↗ |
| K062898 | SBI LATERAL RHEAD IMPLANT | Small Bone Innovations, Inc. | 2006-11-13 | Traditional | PDF ↗ |
| K060731 | EVOLVE MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | 2006-04-19 | Special | PDF ↗ |
| K051385 | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | Acumed, LLC | 2004-10-05 | Traditional | PDF ↗ |
| K040611 | MODULAR RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2004-06-04 | Traditional | PDF ↗ |
| K032806 | KATALYST RADIAL HEAD IMPLANT | Kinetikos Medical, Inc. | 2004-04-16 | Traditional | PDF ↗ |
| K032686 | ASCENSION MODULAR RADIAL HEAD | Ascension Orthopedics, Inc. | 2003-10-22 | Traditional | PDF ↗ |
| K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | Kapp Surgical Instrument, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K030384 | EVOLVE CERAMIC RADIAL HEAD IMPLANT | Wrightmedicaltechnologyinc | 2003-08-12 | Special | PDF ↗ |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2002-11-27 | Special | PDF ↗ |
| K012551 | LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE | Biomet, Inc. | 2002-01-30 | Traditional | PDF ↗ |
| K011819 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-06-19 | Special | PDF ↗ |
| K002644 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2000-11-20 | Traditional | PDF ↗ |
| K994041 | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS | Tornier, Inc. | 2000-08-31 | Traditional | PDF ↗ |
| K001385 | HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS | Howmedica Osteonics Corp. | 2000-07-27 | Traditional | PDF ↗ |
| K000658 | ERS RADIAL HEAD REPLACEMENT | DePuy Orthopaedics, Inc. | 2000-05-11 | Traditional | PDF ↗ |
| K992220 | RADIAL HEAD PROSTHESIS | Smith & Nephew, Inc. | 2000-02-25 | Abbreviated | PDF ↗ |
| K991915 | MODULAR RADIAL HEAD | Wrightmedicaltechnologyinc | 1999-09-03 | Traditional | PDF ↗ |
| K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM | Implex Corp. | 1999-06-01 | Traditional | PDF ↗ |
| K982288 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-09-08 | Traditional | PDF ↗ |
| K944507 | METALLIC RADIAL HEAD IMPLANTS | Wrightmedicaltechnologyinc | 1995-07-13 | Traditional | PDF ↗ |
| K885146 | CL UNIVERSAL HIP DEVICE | Lima Intl. Corp. | 1989-04-24 | Traditional | PDF ↗ |
Product code KWI · Class II · Orthopedic. Data: openFDA.