KWI
- Product code
- KWI
- Device name
- Prosthesis, Elbow, Hemi-, Radial, Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3170
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 34 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260624 | 2026-07-30 | Arthrex, Inc. | Arthrex Radial Head Replacement System | FDA |
| K233592 | 2024-03-13 | BioPoly, LLC | BioPoly Radial Head Implant | |
| K231188 | 2023-09-28 | Skeletal Dynamics, Inc. | ALIGN Radial Head System |
Official FDA classification page: KWI
Classification and pathway per current FDA publications. Data from openFDA (CC0).