KWZ
- Product code
- KWZ
- Device name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3310
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- 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 (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241461 | 2025-07-31 | Medacta International S.A. | Mpact Constrained Liner | |
| K240639 | 2024-04-04 | Depuy Ireland UC | PINNACLETM Constrained Acetabular Liners |
Official FDA classification page: KWZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).