ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

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

Regulation 888.3560

14510(k)s in 12 months (921 all time)
6recalls in 12 months (984 all time)
887recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
Decided510(k)Device and applicantCode
Jan 18, 2024K234011AMF TT Cones
Lima Corporate S.P.A., IT
JWH
Nov 21, 2023K231975PNK Total Knee System
Tjc Life Co., Ltd., KR
JWH
Nov 3, 2023K230078TRAX® CR Total Knee System
Amplitude, FR
JWH
Oct 31, 2023K231947EVOLUTION® Cement Keel
Microport Orthopedics, Inc.
JWH
Oct 25, 2023K233093Balanced Knee® System TriMax PS Plus Tibial Insert
Ortho Development Corporation
JWH
Sep 8, 2023K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
Total Joint Othopedics, Inc.
JWH
Jul 17, 2023K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
Conformis, Inc.
JWH
Jul 17, 2023K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
Exactech, Inc.
JWH
Jun 9, 2023K231037MyKnee UNI-ST
Medacta International S.A., CH
JWH
Jun 2, 2023K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
JWH
May 26, 2023K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
Conformis, Inc.
JWH
May 19, 2023K230537Klassic Knee Revision System
Total Joint Othopedics, Inc.
JWH
May 4, 2023K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR K
Smith & Nephew, Inc.
JWH
Apr 27, 2023K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
Conformis, Inc.
JWH
Apr 6, 2023K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
Encore Medical, L.P Dba Enovis
JWH
Mar 30, 2023K230555Cemented Tibia Baseplate no Taper with JRNY Lock
Smith & Nephew, Inc.
JWH
Mar 21, 2023K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Waldemar Link GmbH & Co. KG, DE
JWH
Mar 17, 2023K230441EMPOWR Stem Extender, 50mm
Encore Medical, L.P Dba Enovis
JWH
Mar 8, 2023K230321Persona™ Personalized Knee System
Zimmer, Inc.
JWH
Feb 4, 2023K222570COPAL knee moulds
Heraeus Medical GmbH, DE
JWH
Jan 5, 2023K223650REMEDY Stemmed Knee Spacer
Osteoremedies, LLC
JWH
Nov 18, 2022K222816Opulent TiNbN Coated Knee
Meril Healthcare Pvt. , Ltd., IN
JWH
Nov 17, 2022K221479Persona Personalized Knee System
Zimmer, Inc.
JWH
Nov 4, 2022K223062World Total Knee System
Signature Orthopaedics Pty, Ltd., AU
JWH
Oct 6, 2022K222700Tibial baseplate, Tibial insert
United Orthopedic Corporation, TW
JWH
Oct 6, 2022K222431b-ONER MOBIO Total Knee System
B-One Ortho, Corp.
JWH
Oct 4, 2022K222380TriVerse Total Knee Replacement System
Signature Orthopaedics Pty, Ltd., AU
JWH
Aug 26, 2022K222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
Corentec Co., Ltd., KR
JWH
Jul 26, 2022K221939Cemented Round Patella with JRNY Pegs
Smith & Nephew, Inc.
JWH
Jul 26, 2022K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint
Conformis, Inc.
JWH
Jul 5, 2022K221337Materialise TKA Guide System
Materialise NV, BE
JWH
Jun 22, 2022K211877Klassic Knee System
Total Joint Orthopedics, Inc.
JWH
May 10, 2022K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint
Conformis, Inc.
JWH
May 4, 2022K220705MyKnee R Pin Positioners
Medacta International S.A., CH
JWH
Apr 26, 2022K220896Legion Inserts with JRNY Lock
Smith & Nephew, Inc.
JWH
Apr 11, 2022K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
Signature Orthopaedics Pty, Ltd., AU
JWH
Apr 1, 2022K213793EMPOWR Revision Knee
Encore Medical L.P.
JWH
Jan 21, 2022K213673b-ONE MOBIO Total Knee System
B-One Ortho, Corp.
JWH
Dec 17, 2021K213381Physica system
Lima Corporate S.P.A., IT
JWH
Dec 9, 2021K212034LOSPA TKR System
Corentec Co., Ltd., KR
JWH
Nov 16, 2021K212839Opulent TiNbN Coated Knee
Meril Healthcare Pvt. , Ltd., IN
JWH
Nov 10, 2021K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Rep
Conformis, Inc.
JWH
Sep 28, 2021K212129Persona® Personalized Knee System
Zimmer Switzerland Manufacturing GmbH, CH
JWH
Sep 23, 2021K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint
Conformis, Inc.
JWH
Sep 16, 2021K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
Waldemar Link GmbH & Co. KG, DE
JWH
Aug 25, 2021K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
Depuy Ireland UC, IE
JWH
Aug 17, 2021K211671Journey II Mid-Level Tibial Inserts
Smith & Nephew, Inc.
JWH
Aug 16, 2021K210695CPM Medical Consultants Tibial Revision Knee System
Cpm Medical Consultants, LLC
JWH
Jul 29, 2021K211664GMK Sphere Revision
Medacta International S.A., CH
JWH
Jul 23, 2021K211602Klassic Knee System
Total Joint Orthopedics, Inc.
JWH

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