JWH
- 产品代码
- JWH
- 器械名称
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3560
- 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)
- 49 件
- 其中 Summary 已存档
- 44 份，可直接下载
- FDA 历史累计 510(k)
- 915 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（49 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261563 | 2026-08-07 | Maxx Orthopedics, Inc. | Freedom Total Knee System (E-Poly Tibial Liners) | |
| K262251 | 2026-07-31 | Globus Medical, Inc. | ACTIFY Total Knee System, ACTIFY 3D Total Knee Sys… | |
| K261734 | 2026-07-23 | Total Joint Orthopedics, Inc. | Klassic Infection Spacer System | |
| K261458 | 2026-06-25 | DePuy Ireland UC | ATTUNE Total Knee System; ATTUNE Cementless Knee Sys… | |
| K261032 | 2026-04-27 | NovoSource | NovoKnee (SteriKnee) | |
| K253793 | 2026-01-06 | Materialise NV | Materialise TKA Guide System | |
| K252974 | 2025-12-19 | Encore Medical L.P. | EMPOWR Knee | |
| K253197 | 2025-11-19 | Depuy Ireland UC | ATTUNE Total Knee System; ATTUNE Revision Sleeve L… | |
| K253314 | 2025-10-29 | Maxx Orthopedics, Inc. | Freedom Infinia Total Knee System | |
| K253144 | 2025-10-22 | Maxx Orthopedics, Inc. | Freedom® Total Knee System Titan PCK Components | |
| K252725 | 2025-09-25 | United Orthopedic Corporation | Stem Extension Line (U2 Total Knee SystemPSA Type) | |
| K251554 | 2025-07-14 | Materialise NV | Materialise TKA Guide System | |
| K251776 | 2025-07-08 | Encore Medical L.P. | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibi… | |
| K251241 | 2025-07-02 | Encore Medical L.P. | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetr… | |
| K251717 | 2025-06-26 | Maxx Orthopedics, Inc. | Freedom® Total Knee System Titanium Tibial Base Pl… | |
| K242410 | 2025-05-08 | Nextstep Arthropedix | NextStep Arthropedix Total Knee System | |
| K250889 | 2025-04-17 | Corentec Co., Ltd. | EXULT Knee Replacement System | |
| K250677 | 2025-04-02 | Smith & Nephew, Inc. | LEGION Total Knee System | |
| K243991 | 2025-03-24 | Total Joint Othopedics, Inc. | Klassic Knee System - Revision Tibial Baseplate | FDA |
| K250382 | 2025-03-13 | Maxx Orthopedics, Inc. | Freedom Total Knee System (All-poly Tibial Plate) | |
| K243724 | 2025-03-06 | Zimmer, Inc. | Persona® Revision Knee System (Persona Revision Solu… | FDA |
| K244039 | 2025-02-28 | Suzhou Microport Orthorecon Co., Ltd. | MedalOne Total Knee System | |
| K243574 | 2025-02-18 | Microport Orthopedics, Inc. | Evolution® Total Knee Systems - Kinematic Alignment … | |
| K243817 | 2025-02-06 | Howmedica Osteonics Corp., Dba Stryker… | Scorpio Universal Dome Patella; Scorpio Total Stabil… | |
| K241180 | 2025-01-14 | Shalby Advanced Technologies | Consensus Knee System with TiNbN | |
| K243295 | 2025-01-13 | Kyocera Medical Technologies, Inc. | Initia Knee System | |
| K243024 | 2024-12-20 | United Orthopedic Corporation | Cellbrick Knee Spacer | |
| K242831 | 2024-12-04 | Howmedica Osteonics Corp., Dba Stryker… | Triathlon Knee System; Triathlon Pro Posterior Stabi… | |
| K243277 | 2024-11-19 | Maxx Orthopedics, Inc. | Freedom® Medial Congruent Liner | |
| K242984 | 2024-10-25 | Ortho Development Corp. | BKS Revision System | |
| K242377 | 2024-10-02 | Osteoremedies, LLC | REMEDY Stemmed Knee Spacer System with All-Poly Tibi… | |
| K241570 | 2024-09-23 | Corin U.S.A. Limited | Unity Total Knee System | FDA |
| K242401 | 2024-09-12 | Corentec Co., Ltd. | EXULT Knee Replacement System | FDA |
| K240683 | 2024-09-11 | Signature Orthopaedics Pty, Ltd. | Rx Knee System | |
| K234044 | 2024-09-06 | Implantcast GmbH | ACS® LD FB Knee System | FDA |
| K242046 | 2024-08-01 | Corentec Co., Ltd. | EXULT Knee Replacement System | |
| K241000 | 2024-07-11 | Depuy Ireland UC | ATTUNE Revision Knee System; DePuy Knee Prosthesis… | |
| K240863 | 2024-07-02 | Maxx Orthopedics, Inc. | Freedom® Total Knee System | |
| K240327 | 2024-06-27 | Unik Orthopedics, Inc. | UNIKO PointCloud Knee Instruments | |
| K240875 | 2024-06-26 | Corin U.S.A. Limited | Unity Knee PS-C Tibial Insert | |
| K240669 | 2024-06-20 | Globus Medical, Inc. | ACTIFY 3D Total Knee System, ACTIFY Total Knee Sys… | |
| K240324 | 2024-04-26 | Encore Medical, L.P. (Dba Enovis) | EMPOWR Revision Symmetric Knee Cones | |
| K230120 | 2024-04-19 | Beijing Keyi Medical Device Technology… | KeYi Total Knee System | |
| K232175 | 2024-04-14 | Beijing Chunlizhengda Medical Instrume… | XN Knee Prosthesis System | |
| K234011 | 2024-01-18 | Lima Corporate S.P.A. | AMF TT Cones | |
| K231975 | 2023-11-21 | Tjc Life Co., Ltd. | PNK Total Knee System | |
| K230078 | 2023-11-03 | Amplitude | TRAX® CR Total Knee System | |
| K231947 | 2023-10-31 | Microport Orthopedics, Inc. | EVOLUTION® Cement Keel | |
| K233093 | 2023-10-25 | Ortho Development Corporation | Balanced Knee® System TriMax PS Plus Tibial Insert |
FDA 官方分类页： JWH
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。