Product code LPH
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3358
- 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 PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P880025S003 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy, Inc. | 1991-12-04 |
| P880076S001 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright | 1991-06-17 |
| P850061S002 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. | 1991-03-08 |
| P880025S001 | DURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM) | Depuy, Inc. | 1991-02-08 |
| P880025S002 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy, Inc. | 1990-10-12 |
| P850061S001 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. | 1989-03-29 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | 2026-06-05 |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 |
| K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026-01-28 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 |
| K252846 | TaperSet™ Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 |
| K243456 | ONVOY™ Acetabular System | Globus Medical, Inc. | 2025-06-06 |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | 2024-10-07 |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024-10-07 |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024-04-18 |
| K231522 | EMPHASYS™ Dual Mobility System | Depuy Ireland UC | 2024-02-15 |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023-10-27 |
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC | 2023-09-20 |
| K230011 | Mpact Extension | Medacta International S.A. | 2023-09-20 |
| K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2023-05-09 |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023-04-14 |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023-02-27 |
| K223779 | EMPOWR™ blade stem | Encore Medical, LLC | 2023-02-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810030812104 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812258 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812241 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812234 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812227 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812210 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812203 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812197 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812180 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812173 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812159 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812142 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812135 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812128 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812111 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812098 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812081 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812074 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812067 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812050 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812043 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030812036 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00810030811992 | InSitu Hip System | NEXTSTEP ARTHROPEDIX, LLC | 2026-06-01 |
| 00885556321942 | REDAPT | Smith & Nephew, Inc. | 2016-02-24 |
| 00885556321393 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321843 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321744 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321690 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321591 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |
| 00885556321492 | REDAPT | Smith & Nephew, Inc. | 2015-12-11 |