LPH
- 产品代码
- LPH
- 器械名称
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3358
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 564 件
该代码近三年的 510(k)（29 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253630 | 2026-08-28 | Medacta International S.A. | Mpact 3D Metal Foam | |
| K254043 | 2026-08-04 | Globus Medical, Inc. | TRIVANCE Hip Stem | |
| K261624 | 2026-07-10 | Howmedica Osteonics Corp., Dba Stryker | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° | FDA |
| K243192 | 2026-06-05 | Nextstep Arthopedix, LLC | iNSitu Lateralized Acetabular Liners, iNSitu Femoral | |
| K251270 | 2026-05-19 | Biomet, Inc. | Taperloc® Complete Hip Stem | |
| K252623 | 2026-02-04 | Zimmer, Inc. | G7® Revision Acetabular System | |
| K251043 | 2026-01-28 | Medacta International S.A. | Mpact 3D Metal Implants Extension DMLS Technology | |
| K252067 | 2025-12-05 | Restor3D, Inc. | Velora Acetabular System | |
| K252846 | 2025-11-20 | Shalby Advanced Technologies, Inc. Dba | TaperSet Hip System | |
| K251833 | 2025-11-12 | Encore Medical L.P. | EMPOWR Acetabular® Liner Extension | |
| K251718 | 2025-08-29 | Lima Corporate S.P.A. | ArTT Augments and Buttresses and Bone Screws | |
| K250989 | 2025-07-25 | Howmedica Osteonics Corp (Dba Stryker | Stryker and Serf hip devices | |
| K243456 | 2025-06-06 | Globus Medical, Inc. | ONVOY Acetabular System | |
| K242744 | 2025-06-05 | Corin U.S.A. Limited | Trinity EVO Acetabular Shell | FDA |
| K242232 | 2025-04-23 | Medacta International S.A. | Mpact 3D Metal Augments II | |
| K242045 | 2025-04-10 | Kyocera Medical Technologies, Inc. | Initia T3 Acetabular Hemispherical Shell System | |
| K243784 | 2025-02-06 | Howmedica Osteonics Corp., Dba Stryker | Stryker Orthopaedics Hip Devices Labeling Update | |
| K243977 | 2025-01-22 | Depuy Ireland UC | EMPHASYS Acetabular System | |
| K241059 | 2025-01-13 | Adler Ortho S.P.A | Pantheon Proximal Femur Reconstruction (PFR) System | |
| K241636 | 2024-11-08 | Waldemar Link GmbH & Co. KG | MobileLink Acetabular Cup System - Line Extension (M | |
| K242833 | 2024-10-11 | Ortho Development Corp. | Legend® Acetabular Shell | |
| K242375 | 2024-10-07 | Smith & Nephew, Inc. | OR3O Dual Mobility System | |
| K242084 | 2024-10-07 | Depuy Ireland UC | EMPHASYS Acetabular Shell with RapiTite HA | FDA |
| K240046 | 2024-04-18 | Microport Orthopedics | Ethylene Oxide Sterilization Supplier Change for MPO | |
| K231522 | 2024-02-15 | Depuy Ireland UC | EMPHASYS Dual Mobility System | |
| K233498 | 2023-12-21 | Howmedica Osteonics Corp., Dba Stryker | Stryker Orthopaedics Hip Systems Labeling Update | |
| K232667 | 2023-10-27 | Smith & Nephew, Inc. | OR3O Dual Mobility Liners | |
| K232556 | 2023-09-20 | Depuy Ireland UC | DePuy 3D Additive TriFlange Acetabular Cup and DePuy | |
| K230011 | 2023-09-20 | Medacta International S.A. | Mpact Extension |
FDA 官方分类页： LPH
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。