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

Pre-market Notifications for JWH

K223062World Total Knee SystemSignature Orthopaedics Pty Ltd.
K222816Opulent TiNbN Coated KneeMeril Healthcare Pvt. Ltd.
K222700Tibial Baseplate, Tibial InsertUnited Orthopedic Corporation
K222431B-ONER MOBIO Total Knee SystemB-ONE ORTHO, Corp.
K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.
K221479Persona Personalized Knee SystemZimmer, Inc.
K221337Materialise TKA Guide SystemMaterialise NV
K220896Legion Inserts With JRNY LockSmith & Nephew, Inc.
K220737World 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.
K220705MyKnee R Pin PositionersMedacta International S.A.
K213793EMPOWR Revision KneeEncore Medical, L.P.
K213673B-ONE MOBIO Total Knee SystemB-ONE ORTHO, Corp.
K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System And Identity Imprint Posterior Stabilized (PS) Knee Replacement SystemConformis Inc.
K213381Physica SystemLimaCorporate S.p.A
K212742GEMINI SL Total Knee System, Endo-Model Knee System, And Sled Knee System With LINK PorEx (TiNbN) Inhouse CoatingWaldemar Link GmbH & Co. KG

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

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