KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer Class II
FDA product code KWI covers "Prosthesis, Elbow, Hemi-, Radial, Polymer", a Class II medical device regulated under 21 CFR 888.3170. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWI
- Device Class
- Class II
- Regulation Number
- 888.3170
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233592 | biopoly | BioPoly Radial Head Implant | March 13, 2024 |
| K231188 | skeletal dynamics | ALIGN Radial Head System | September 28, 2023 |
| K213563 | depuy synthes | DePuy Synthes Radial Head Replacement System | March 18, 2022 |
| K212872 | in2bones usa | Avenger Radial Head System | December 17, 2021 |
| K192754 | in2bones usa | Avenger Radial Head System | January 7, 2020 |
| K183618 | ignite orthopedics | Revolution Radial Head | May 17, 2019 |
| K172688 | skeletal dynamics | Align Radial Head System | December 22, 2017 |
| K132735 | imds (innovative medical device systems) - leis me | AXIA RADIAL HEAD SYSTEM | January 7, 2014 |
| K131845 | acumed | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUM | September 30, 2013 |
| K112030 | synthes usa | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM | June 19, 2012 |
| K092721 | skeletal dynamics | ALIGN RADIAL HEAD SYSTEM | August 3, 2010 |
| K062898 | small bone innovations | SBI LATERAL RHEAD IMPLANT | November 13, 2006 |
| K060731 | wrightmedicaltechnologyinc | EVOLVE MODULAR RADIAL HEAD | April 19, 2006 |
| K051385 | biomet | EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE | August 5, 2005 |
| K041858 | acumed | ACUMED ANATOMIC RADIAL HEAD SYSTEM | October 5, 2004 |
| K040611 | biomet | MODULAR RADIAL HEAD REPLACEMENT DEVICE | June 4, 2004 |
| K032806 | kinetikos medical | KATALYST RADIAL HEAD IMPLANT | April 16, 2004 |
| K032686 | ascension orthopedics | ASCENSION MODULAR RADIAL HEAD | October 22, 2003 |
| K030237 | kapp surgical instrument | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT | August 29, 2003 |
| K030384 | wrightmedicaltechnologyinc | EVOLVE CERAMIC RADIAL HEAD IMPLANT | August 12, 2003 |