Product code MEH
- Device name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3353
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261576 | Icona Hip Stem | Corin, Ltd. | 2026-08-10 |
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025-05-01 |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024-10-03 |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024-09-13 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024-03-08 |
| 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 Bas... | Depuy Ireland UC | 2024-01-19 |
| K231178 | ACTERA™ hip system | Conformis, Inc. | 2023-05-23 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022-08-11 |
| K221104 | Actera™ hip system | Conformis, Inc. | 2022-08-04 |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | 2021-09-24 |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021-08-16 |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021-05-20 |
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020-10-16 |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020-09-21 |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020-02-04 |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019-03-25 |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018-04-11 |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018-01-19 |
| K171249 | Entrada™ hip stem | Ortho Development Corporation | 2017-08-24 |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017-05-01 |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | 2017-04-26 |
| K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | 2016-08-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719886896503 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896671 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896664 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896657 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896640 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896633 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896596 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896589 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896572 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896565 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896558 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896541 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896534 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896527 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896510 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896497 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896480 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896473 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04719886896466 | United Hip System | UNITED ORTHOPEDIC CORP. | 2026-09-24 |
| 04546540273260 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540432001 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402189 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402172 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402165 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540402158 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273390 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273369 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273345 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273314 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |
| 04546540273291 | Orthinox | Howmedica Osteonics Corp. | 2015-09-24 |