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
May 16, 2019K190355Precision Casting Solutions Total Knee System
Precision Casting Solutions, Inc.
JWH
May 16, 2019K182251EVOLUTION NitrX Medial-Pivot Knee
Mircoport Orthopedics, Inc.
JWH
May 10, 2019K183583Vanguard Complete Knee System
Zimmer, Inc.
JWH
Apr 27, 2019K181732InterSpace Knee Extra-Large Size, InterSpace Knee ATS
Tecres S.P.A., IT
JWH
Apr 3, 2019K182872LINK GEMINI SL Total Knee System
Waldemar Link GmbH & Co. KG, DE
JWH
Mar 29, 2019K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Ins
Total Joint Orthopedics, Inc.
JWH
Mar 18, 2019K183344The Progressive Orthopaedic Company Total Knee System II
The Progressive Orthopaedic Company, LLC
JWH
Mar 15, 2019K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
Total Joint Orthopedics, Inc.
JWH
Feb 15, 2019K183225Stabil Orthopaedic Solutions Total Knee System
Stabil Orthopaedic Solutions, LLC
JWH
Jan 28, 2019K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
B-One Ortho, Corp.
JWH
Jan 22, 2019K182574Freedom Ultra-Congruent CR Tibial Liner
Maxx Orthopedics, Inc.
JWH
Jan 17, 2019K181338Imboki Knee Instrument System
Signature Orthopaedics Pty, Ltd., AU
JWH
Dec 6, 2018K182125EVOLUTION Stemmed CS Femur
Microport Orthopedics, Inc.
JWH
Nov 28, 2018K183010Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
Smith & Nephew, Inc.
JWH
Oct 31, 2018K182085Balanced Knee Revision System Trabecular Tibial Cone Augments
Ortho Development Corporation
JWH
Oct 25, 2018K181947Persona Revision Knee System
Zimmer, Inc.
JWH
Oct 24, 2018K181530World Total Knee System
Signature Orthopaedics Pty, Ltd., AU
JWH
Oct 12, 2018K181569BKS Revision Sleeves System
Ortho Development Corporation
JWH
Oct 12, 2018K180446b-ONE Total Knee System
B-One Ortho, Corp.
JWH
Sep 27, 2018K182370Acculoc Total Knee System
Rootloc Co., Ltd., KR
JWH
Aug 23, 2018K181635GMK Sphere CR Tibial Inserts
Medacta International S.A., CH
JWH
Aug 23, 2018K173890GMK Sphere - Kinematic Alignment
Medacta International S.A., CH
JWH
Aug 3, 2018K181146ASK System
L and K Biomed Corporation Limited, KR
JWH
Jul 9, 2018K180930EMPOWR VVC TIBIAL INSERT
Encore Medical L.P.
JWH
Jun 22, 2018K180493A3 Total Knee System
Beijing AK Medical Co., Ltd., CN
JWH
Jun 20, 2018K180743Balanced Knee Revision System - Offset Junction Box
Ortho Development Corporation
JWH
May 16, 2018K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Conformis, Inc.
JWH
Apr 20, 2018K180750World Knee System
Signature Orthopaedics Pty, Ltd., AU
JWH
Mar 29, 2018K173057Zimmer Knee Joint Replacement Prostheses MR Labeling
Zimmer, Inc.
JWH
Mar 23, 2018K170753Acculoc Total Knee System
Rootloc Co., Ltd., KR
JWH
Mar 9, 2018K180159Klassic® Knee System
Total Joint Orthopedics, Inc.
JWH
Mar 5, 2018K180334LEGION Knee System
Smith & Nephew, Inc.
JWH
Mar 5, 2018K173723EMPOWR Universal Tibial Baseplate
Encore Medical L.P.
JWH
Feb 2, 2018K173445Materialise TKA Guide System
Materialise NV, BE
JWH
Jan 19, 2018K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
Stelkast, Inc.
JWH
Jan 17, 2018K173884Unity Total Knee System
Corin U.S.A. Limited
JWH
Jan 10, 2018K172336Smith & Nephew Patient Matched Cutting Blocks
Smith & Nephew, Inc.
JWH
Dec 28, 2017K171269X-PSI Knee System
Orthosoft Inc (D/B/A Zimmer Cas), CA
JWH
Nov 30, 2017K172936Destiknee™ Total Knee System
Meril Healthcare Pvt. , Ltd., IN
JWH
Nov 16, 2017K173331JOURNEY II XR Knee Instruments
Smith & Nephew, Inc.
JWH
Nov 9, 2017K170534PROLIXUS TOTAL KNEE SYSTEM
Otis Biotech Co., Ltd., KR
JWH
Oct 30, 2017K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
Stryker Orthopaedics
JWH
Oct 20, 2017K170106MyKnee PPS-Pin Positioners
Medacta International S.A., CH
JWH
Aug 18, 2017K1701493DMetal Tibial Cones
Medacta International S.A., CH
JWH
Aug 9, 2017K163167CKS Plus Knee System
Consensus Orthopedics, Inc.
JWH
Aug 8, 2017K171389EVOLUTION Revision CCK System
Microport Orthopedics, Inc.
JWH
Jul 28, 2017K171054Biomet Knee Joint Replacement Prostheses
Biomet, Inc.
JWH
Jul 17, 2017K170613Genius Total Knee System
Signature Orthopaedics Pty, Ltd., AU
JWH
Jul 13, 2017K170808Unity Total Knee System
Corin U.S.A. Limited
JWH
Jun 15, 2017K170806ATTUNE Cemented Tibial Base, Fixed Bearing
Depuy(Ireland), IE
JWH

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