会员EN

JWH

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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)
915 件

该代码近三年的 510(k)（49 件）

数据窗口为最近三年。最新一件：2026-08-07。

510(k) 号批准日期申请人器械名称
K2615632026-08-07Maxx Orthopedics, Inc.Freedom Total Knee System (E-Poly Tibial Liners) 摘要
K2622512026-07-31Globus Medical, Inc.ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee Sys 摘要
K2617342026-07-23Total Joint Orthopedics, Inc.Klassic Infection Spacer System 摘要
K2614582026-06-25DePuy Ireland UCATTUNE Total Knee System; ATTUNE Cementless Knee Sys 摘要
K2610322026-04-27NovoSourceNovoKnee (SteriKnee) 摘要
K2537932026-01-06Materialise NVMaterialise TKA Guide System 摘要
K2529742025-12-19Encore Medical L.P.EMPOWR Knee 摘要
K2531972025-11-19Depuy Ireland UCATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve L 摘要
K2533142025-10-29Maxx Orthopedics, Inc.Freedom Infinia™ Total Knee System 摘要
K2531442025-10-22Maxx Orthopedics, Inc.Freedom® Total Knee System – Titan PCK Components 摘要
K2527252025-09-25United Orthopedic CorporationStem Extension Line (U2 Total Knee System—PSA Type) 摘要
K2515542025-07-14Materialise NVMaterialise TKA Guide System 摘要
K2517762025-07-08Encore Medical L.P.EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibi 摘要
K2512412025-07-02Encore Medical L.P.EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetr 摘要
K2517172025-06-26Maxx Orthopedics, Inc.Freedom® Total Knee System – Titanium Tibial Base Pl 摘要
K2424102025-05-08Nextstep ArthropedixNextStep Arthropedix Total Knee System 摘要
K2508892025-04-17Corentec Co., Ltd.EXULT Knee Replacement System 摘要
K2506772025-04-02Smith & Nephew, Inc.LEGION Total Knee System 摘要
K2439912025-03-24Total Joint Othopedics, Inc.Klassic Knee System - Revision Tibial Baseplate 摘要
K2503822025-03-13Maxx Orthopedics, Inc.Freedom Total Knee System (All-poly Tibial Plate) 摘要
K2437242025-03-06Zimmer, Inc.Persona® Revision Knee System (Persona Revision Solu 摘要
K2440392025-02-28Suzhou Microport Orthorecon Co., Ltd.MedalOne Total Knee System 摘要
K2435742025-02-18Microport Orthopedics, Inc.Evolution® Total Knee Systems - Kinematic Alignment 摘要
K2438172025-02-06Howmedica Osteonics Corp., Dba StrykerScorpio Universal Dome Patella; Scorpio Total Stabil 摘要
K2411802025-01-14Shalby Advanced TechnologiesConsensus Knee System with TiNbN 摘要
K2432952025-01-13Kyocera Medical Technologies, Inc.Initia Knee System 摘要
K2430242024-12-20United Orthopedic CorporationCellbrick Knee Spacer 摘要
K2428312024-12-04Howmedica Osteonics Corp., Dba StrykerTriathlon Knee System; Triathlon Pro Posterior Stabi 摘要
K2432772024-11-19Maxx Orthopedics, Inc.Freedom® Medial Congruent Liner 摘要
K2429842024-10-25Ortho Development Corp.BKS Revision System 摘要
K2423772024-10-02Osteoremedies, LLCREMEDY Stemmed Knee Spacer System with All-Poly Tibi 摘要
K2415702024-09-23Corin U.S.A. LimitedUnity Total Knee System 摘要
K2424012024-09-12Corentec Co., Ltd.EXULT Knee Replacement System 摘要
K2406832024-09-11Signature Orthopaedics Pty, Ltd.Rx Knee System 摘要
K2340442024-09-06Implantcast GmbHACS® LD FB Knee System 摘要
K2420462024-08-01Corentec Co., Ltd.EXULT Knee Replacement System 摘要
K2410002024-07-11Depuy Ireland UCATTUNE™ Revision Knee System; DePuy Knee Prosthesis 摘要
K2408632024-07-02Maxx Orthopedics, Inc.Freedom® Total Knee System 摘要
K2403272024-06-27Unik Orthopedics, Inc.UNIKO PointCloud™ Knee Instruments 摘要
K2408752024-06-26Corin U.S.A. LimitedUnity Knee PS-C Tibial Insert 摘要
K2406692024-06-20Globus Medical, Inc.ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee Sys 摘要
K2403242024-04-26Encore Medical, L.P. (Dba Enovis)EMPOWR Revision Symmetric Knee Cones 摘要
K2301202024-04-19Beijing Keyi Medical Device TechnologyKeYi Total Knee System 摘要
K2321752024-04-14Beijing Chunlizhengda Medical InstrumeXN Knee Prosthesis System 摘要
K2340112024-01-18Lima Corporate S.P.A.AMF TT Cones 摘要
K2319752023-11-21Tjc Life Co., Ltd.PNK Total Knee System 摘要
K2300782023-11-03AmplitudeTRAX® CR Total Knee System 摘要
K2319472023-10-31Microport Orthopedics, Inc.EVOLUTION® Cement Keel 摘要
K2330932023-10-25Ortho Development CorporationBalanced Knee® System TriMax PS Plus Tibial Insert 摘要
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。