MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class II
FDA product code MEH covers "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate", a Class II medical device regulated under 21 CFR 888.3353. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MEH
- Device Class
- Class II
- Regulation Number
- 888.3353
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250375 | waldemar link gmbh and co. kg | Allure Hip Stem and Intramedullary Plugs | November 5, 2025 |
| K251166 | medacta international | Mfinity Femoral System | June 13, 2025 |
| K251052 | ortho development | Trivicta® Hip Stem | May 22, 2025 |
| K242315 | united orthopedic corporation | Resolve Modular Revision Hip Stem | May 1, 2025 |
| K243839 | exactech | Alteon® HA Femoral Stems | March 10, 2025 |
| K243162 | signature orthopaedics pty | World Liner | November 25, 2024 |
| K241472 | corin u.s.a. limited | Icona Hip Stem | October 3, 2024 |
| K241875 | nextstep arthropedix | TheRay Collared and Collarless Femoral Stem | September 13, 2024 |
| K241690 | signature orthopaedics pty | Logical Liner; World Liner; World Knee Patella | August 1, 2024 |
| K233758 | ortho development | Trivicta Hip Stem | March 8, 2024 |
| K231873 | depuy ireland uc | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip P | January 19, 2024 |
| K231178 | conformis | ACTERA hip system | May 23, 2023 |
| K220495 | signature orthopaedics pty | SignaSure Dual Mobility System | January 13, 2023 |
| K220731 | stryker | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | August 11, 2022 |
| K221104 | conformis | Actera hip system | August 4, 2022 |
| K211742 | signature orthopaedics pty | SignaSure Dual Mobility System | January 7, 2022 |
| K211505 | signature orthopaedics pty | Encore Hip Stem | September 24, 2021 |
| K211703 | stryker orthopaedics | Insignia Hip Stem | August 16, 2021 |
| K210581 | depuy ireland uc | Actis DuoFix Hip Prosthesis- Collarless | May 20, 2021 |
| K200045 | implantcast | MUTARS Cemented Femoral Stems | October 16, 2020 |