Product Code: JWH


Products Classified as JWH

4539Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymerKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4539Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymerKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [34059]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [38231]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [37410]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [37411]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [32800]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [31877]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [33508]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [34714]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [32210]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [33115]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [31869]21 CFR §888.3560 ๐Ÿ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer [38290]21 CFR §888.3560 ๐Ÿ”Ž

Pre-market Notifications for JWH

K211866Bencox THR SystemCorentec Co., Ltd.
K211664GMK Sphere RevisionMedacta International S.A.
K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.
K211004GMK Spherika Femurs And Fixed Tibial Trays PlusMedacta International SA
K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation
K210809ITotalยฎ Identityโ„ข Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.
K210551Persona Revision Knee SystemZimmer, Inc.
K210483MOBIO Total Knee SystemB-ONE ORTHO, Corp.
K210252ITotal Identity Cruciate Retaining (CR) Knee Replacement System, ITotal Identity Posterior Stabilizing (PS) Knee Replacement SystemConformis Inc.
K210191Identity Imprint Knee Replacement SystemConformis Inc.
K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG
K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.
K202684GMK Total Knee System - TiNbN CoatingMedacta International SA
K202429Mobio Total Knee SystemB-One Ortho, Corp.
K202022GMK-SPHERE Tibial Inserts FLEX Tibial Insert CR And Resurfacing Patella Made Of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)Medacta International SA

Global Unique Device Identification Database

00643169778337PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778320PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778313PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778306PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778290PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778283PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778276PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778245PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778221PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169778214PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169774582PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169774575PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169774568PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169774551PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
00643169774544PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Maude Adverse Events

FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFTZIMMER BIOMET, INC.2020-03-31
ATTUNE CR FEM LT SZ 6 CEMDEPUY IRELAND - 96166712020-03-31
ATTUNE FB TIB BASE SZ 5 CEMDEPUY IRELAND - 96166712020-03-31
ATTUNE CR FB INSRT SZ 6 8MMDEPUY IRELAND - 96166712020-03-31
ATTUNE MEDIAL DOME PAT 29MMDEPUY IRELAND - 96166712020-03-31
APEX KNEEOMNILIFE SCIENCE INC.2020-03-31
LPS DISTAL FEM COMP XSM RTDEPUY ORTHOPAEDICS INC US2020-03-31
PERSONA TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2020-03-31
ATTUNE MEDIAL DOME PAT 38MMDEPUY IRELAND - 96166712020-03-31
ATTUNE CR FB INSRT SZ 8 5MMDEPUY IRELAND - 96166712020-03-31
ATTUNE CR FEM RT SZ 7 CEMDEPUY IRELAND - 96166712020-03-31
ATUN FEM SLV M/L 35MM FULL PORDEPUY IRELAND - 96166712020-03-31
NEXGEN BEARING COMPONENTZIMMER BIOMET, INC.2020-03-31
NEXGEN TIBIAL TRAY COMPONENTZIMMER BIOMET, INC.2020-03-31
CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2020-03-31
NEXGEN FEMORAL COMPONENTZIMMER BIOMET, INC.2020-03-31
SIGMA PS CEM FEM SZ4 RDEPUY ORTHOPAEDICS INC US2020-03-31
PFC*SIGMA/OV/DOME PAT 3PEG,41DEPUY ORTHOPAEDICS INC US2020-03-31
MTS KNEEENCORE MEDICAL L.P.2020-03-31
EMPOWR 3D KNEEENCORE MEDICAL L.P.2020-03-31
ATTUNE FB TIB BASE SZ 7 CEMDEPUY IRELAND - 96166712020-03-31
UNKNOWN KNEE TIBIAL INSERTDEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN KNEE TIBIAL TRAYDEPUY ORTHOPAEDICS INC US2020-03-31
AS VEGA PS TIBIAL PLATEAU CEMENTED T1AESCULAP AG2020-03-31
AS VEGA PS TIBIAL PLATEAU CEMENTED T2AESCULAP AG2020-03-31
AS VEGA PS FEMORAL COMP.CEMENTED F4N RAESCULAP AG2020-03-31
UNKNOWN KNEE FEMORALDEPUY ORTHOPAEDICS INC US2020-03-31
KNEE-DUMMY IMPLANTSMITH & NEPHEW, INC.2020-03-31
ATTUNE CR FEM LT SZ 10 CEMDEPUY IRELAND - 96166712020-03-31
ATTUNE CR FB INSRT SZ 10 5MMDEPUY IRELAND - 96166712020-03-31
ATTUNE FB TIB BASE SZ 10 CEMDEPUY ORTHOPAEDICS INC US2020-03-31
ATTUNE MEDIAL DOME PAT 41MMDEPUY IRELAND - 96166712020-03-31
JRNY II XR INS XLPE LAT 3-4 LT 8MMSMITH & NEPHEW, INC.2020-03-31
PFC* 3-POST RND DOME PAT 38MMDEPUY ORTHOPAEDICS INC US2020-03-31
PFCSIGMA C/R FEM CEM LFTSZ3DNIDEPUY ORTHOPAEDICS INC US2020-03-31
PFC*SIGMA/OV/DOME PAT 3PEG,41DEPUY ORTHOPAEDICS INC US2020-03-31
PFC*SIGMA TC3 FEM LEFT SZ4DEPUY ORTHOPAEDICS INC US2020-03-31
UNK ATTUNE FEMORALDEPUY IRELAND - 96166712020-03-31
PERSONA CEMENTED STEMMED TIBIAL COMPONENT SIZE E RIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-31
PERSONA CRUCIATE RETAINING ARTICULAR SURFACE 11MM RIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-31
PERSONA CRUCIATE RETAINING CEMENTED FEMORAL COMPONENT SIZE 6 RIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-31
JRNY BCS II FEMORAL OXIN LT SZ 5SMITH & NEPHEW, INC.2020-03-31
KNEE-DUMMY IMPLANTSMITH & NEPHEW, INC.2020-03-31
ATTUNE PS FB INSRT SZ 4 6MMDEPUY IRELAND - 96166712020-03-31
ATTUNE FB TIB BASE SZ 3 CEMDEPUY IRELAND - 96166712020-03-31
ATTUNE FB TIB BASE SZ 7 CEMDEPUY IRELAND - 96166712020-03-31
ATTUNE PS FEM RT SZ 6 CEMDEPUY IRELAND - 96166712020-03-31
GENESIS II TOTAL KNEE REPLACEMENT SYSTEMSMITH AND NEPHEW, INC.2020-03-30
GENESIS II TOTAL KNEE REPLACEMENT SYSTEMSMITH AND NEPHEW, INC.2020-03-30
GENESIS II TOTAL KNEE REPLACEMENT SYSTEMSMITH AND NEPHEW, INC.2020-03-30

ยฉ 2021 FDA.report
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