MEH · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Orthopedic · 21 CFR 888.3353 · Class 2
Overview
| Product Code | MEH |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Regulation | 21 CFR 888.3353 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 159)
Showing 20 most recent of 159 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | Nov 5, 2025 | SESE |
| K251166 | Mfinity Femoral System | Medacta International S.A. | Jun 13, 2025 | SESE |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | May 22, 2025 | SESE |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | May 1, 2025 | SESE |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | Mar 10, 2025 | SESE |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | Nov 25, 2024 | SESE |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | Oct 3, 2024 | SESE |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | Sep 13, 2024 | SESE |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | Aug 1, 2024 | SESE |
| K233758 | Trivicta Hip Stem | Ortho Development Corp. | Mar 8, 2024 | SESE |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC | Jan 19, 2024 | SESE |
| K231178 | ACTERA hip system | Conformis, Inc. | May 23, 2023 | SESE |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | Jan 13, 2023 | SESE |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | Aug 11, 2022 | SESE |
| K221104 | Actera hip system | Conformis, Inc. | Aug 4, 2022 | SESE |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | Jan 7, 2022 | SESE |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | Sep 24, 2021 | SESE |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | Aug 16, 2021 | SESE |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | May 20, 2021 | SESE |
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | Oct 16, 2020 | SESE |
Top Applicants
- Osteonics Corp. — 24 clearances
- Howmedica Osteonics Corp. — 19 clearances
- Smith & Nephew, Inc. — 13 clearances
- Signature Orthopaedics Pty, Ltd. — 8 clearances
- Exactech, Inc. — 8 clearances
