KWY
- Product code
- KWY
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3390
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 99 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253357 | 2026-04-13 | B-One Ortho, Corp. | b-ONE® Bipolar Head | |
| K243634 | 2025-08-25 | Maxx Orthopedics, Inc. | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | |
| K231526 | 2023-12-19 | Depuy Ireland UC | CORAIL Cemented Femoral Stem |
Official FDA classification page: KWY
Classification and pathway per current FDA publications. Data from openFDA (CC0).