KWD
- Product code
- KWD
- Device name
- Prosthesis, Toe, Hemi-, Phalangeal
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3730
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 46 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250074 | 2026-04-03 | Hyalex Orthopaedics, Inc. | HYALEX® MTP Hemiarthroplasty Implant | FDA |
| K240268 | 2024-02-29 | Accufix Surgical, Inc. | Accu-Joint Hemi Implant |
Official FDA classification page: KWD
Classification and pathway per current FDA publications. Data from openFDA (CC0).