KWIClass II
Prosthesis, Elbow, Hemi-, Radial, Polymer
21 CFR 888.3170 / Orthopedic
KWI is the FDA product code for Prosthesis, Elbow, Hemi-, Radial, Polymer, a class II device type, regulated under 21 CFR 888.3170. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 30 recalls.
Classification record
- Product code
- KWI
- Device name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Regulation
- 21 CFR 888.3170
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 34
- Ingested recalls
- 30
Clearances, product code KWI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code KWI| Applicant | Clearances |
|---|---|
| Avanta Orthopaedics, Inc. | 4 |
| Wrightmedicaltechnologyinc | 4 |
| Zimmer GmbH | 3 |
| Skeletal Dynamics, Inc | 3 |
| Acumed LLC | 2 |
| In2bones USA, LLC | 2 |
| Arthrex GmbH | 1 |
| Ascension Orthopedics, Inc. | 1 |
| Biopoly, LLC | 1 |
| Depuy Orthopaedics Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.