MEH
- Product code
- MEH
- Device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3353
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 160 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261576 | 2026-08-10 | Corin, Ltd. | Icona Hip Stem | FDA |
| K250375 | 2025-11-05 | Waldemar Link GmbH & Co. KG | Allure Hip Stem and Intramedullary Plugs | |
| K251166 | 2025-06-13 | Medacta International S.A. | Mfinity Femoral System | |
| K251052 | 2025-05-22 | Ortho Development Corp. | Trivicta® Hip Stem | |
| K242315 | 2025-05-01 | United Orthopedic Corporation | Resolve Modular Revision Hip Stem | |
| K243839 | 2025-03-10 | Exactech, Inc. | Alteon® HA Femoral Stems | |
| K243162 | 2024-11-25 | Signature Orthopaedics Pty, Ltd. | World Liner | |
| K241472 | 2024-10-03 | Corin U.S.A. Limited | Icona Hip Stem | FDA |
| K241875 | 2024-09-13 | Nextstep Arthropedix | TheRay Collared and Collarless Femoral Stem | |
| K241690 | 2024-08-01 | Signature Orthopaedics Pty, Ltd. | Logical Liner; World Liner; World Knee Patella | |
| K233758 | 2024-03-08 | Ortho Development Corp. | Trivicta Hip Stem | |
| K231873 | 2024-01-19 | Depuy Ireland UC | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditiona… |
Official FDA classification page: MEH
Classification and pathway per current FDA publications. Data from openFDA (CC0).