Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Device Code: 4539

Product Code(s): JWH

Device Classification Information

Device Type ID4539
Device NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Regulation DescriptionKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
CFR Regulation Number888.3560 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJWH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4539
DeviceProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Product CodeJWH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.
CFR Regulation Number888.3560 [🔎]
Premarket Reviews
ManufacturerDecision
AESCULAP
 
SUBSTANTIALLY EQUIVALENT
 1
AESCULAP IMPLANT SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
AESCULAP IMPLANT SYSTEMS, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
AMPLITUDE
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 4
CONFORMIS INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CONFORMIS, INC.
 
SUBSTANTIALLY EQUIVALENT
 11
CONSENSUS ORTHOPEDICS, INC
 
SUBSTANTIALLY EQUIVALENT
 1
CONSENSUS ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
CORENTEC CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
CORIN USA LIMITED
 
SUBSTANTIALLY EQUIVALENT
 2
DEPUY SYNTHES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ENCORE MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 7
ENCORE MEDICAL, L.P.
 
SUBSTANTIALLY EQUIVALENT
 7
EXACTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
LIMACORPORATE S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 3
MATERIALISE N.V.
 
SUBSTANTIALLY EQUIVALENT
 3
MATORTHO
 
SUBSTANTIALLY EQUIVALENT
 1
MAXX ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDACTA INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 5
MERIL HEALTHCARE PVT. LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MICROPORT ORTHOPEDICS INC.
 
SUBSTANTIALLY EQUIVALENT
 3
MICROPORT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
OMNILIFE SCIENCE
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHO DEVELOPMENT
 
SUBSTANTIALLY EQUIVALENT
 5
ORTHO DEVELOPMENT CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 5
SMITH & NEPHEW, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 14
STELKAST
 
SUBSTANTIALLY EQUIVALENT
 2
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER ORTHOPAEDICS
 
SUBSTANTIALLY EQUIVALENT
 1
TOTAL JOINT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 8
UNITED ORTHOPEDIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 7
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 3
ZIMMER INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
Device Problems
Insufficient Information
 13032
Adverse Event Without Identified Device Or Use Problem
 3773
Fracture
 3200
Loss Of Or Failure To Bond
 2296
Break
 2154
Migration Or Expulsion Of Device
1822
Appropriate Term/Code Not Available
 1337
Unstable
 1310
Naturally Worn
 1081
Failure To Adhere Or Bond
 863
Loose Or Intermittent Connection
 813
Component Missing
626
Device Dislodged Or Dislocated
 534
Noise, Audible
 502
Disassembly
 478
Loss Of Osseointegration
 465
Difficult To Insert
 405
Malposition Of Device
373
Loosening Of Implant Not Related To Bone-Ingrowth
 248
Device Operates Differently Than Expected
 199
Material Integrity Problem
 194
Crack
 179
Migration
 168
Device Contamination With Chemical Or Other Material
 161
Fitting Problem
 160
Mechanical Problem
 149
Scratched Material
 140
Inadequacy Of Device Shape And/or Size
 137
Detachment Of Device Or Device Component
 132
Detachment Of Device Component
 130
Packaging Problem
 126
Unintended Movement
 120
Osseointegration Problem
 106
Device Slipped
 102
Degraded
 100
Device Packaging Compromised
 86
Material Deformation
 85
Material Erosion
 78
Difficult To Position
 67
Tear, Rip Or Hole In Device Packaging
 65
Material Discolored
 64
Positioning Problem
 62
Metal Shedding Debris
 58
Use Of Device Problem
 53
Connection Problem
 40
Mechanical Jam
 39
Manufacturing, Packaging Or Shipping Problem
 38
Delivered As Unsterile Product
 36
No Apparent Adverse Event
 36
Defective Device
 35
Device Markings / Labelling Problem
 34
Patient-Device Incompatibility
 33
Off-Label Use
 32
Device Contaminated During Manufacture Or Shipping
 30
Corroded
30
Bent
 29
Improper Or Incorrect Procedure Or Method
 27
Material Separation
 26
Material Fragmentation
 25
Device-Device Incompatibility
 25
Physical Resistance / Sticking
 25
Peeled / Delaminated
 25
Compatibility Problem
 23
Residue After Decontamination
 23
Device Damaged Prior To Use
22
Failure To Align
 22
Component Incompatible
 20
Device Issue
 20
Screw
 20
Misconnection
 20
Material Disintegration
 20
Difficult To Remove
20
Pitted
 18
Defective Component
 18
Unsealed Device Packaging
 18
Device Damaged By Another Device
 18
Device Or Device Fragments Location Unknown
 17
Material Twisted / Bent
 17
Incorrect Measurement
 17
Incorrect Device Or Component Shipped
 16
Patient Device Interaction Problem
 15
Separation Problem
14
Misassembled
 13
Device Abrasion From Instrument Or Another Object
 12
Material Too Rigid Or Stiff
 12
Incomplete Or Missing Packaging
 11
Sticking
 11
Delamination
 11
Contamination / Decontamination Problem
10
Pin
 10
Material Distortion
 10
Disconnection
 9
Difficult To Open Or Remove Packaging Material
 9
Collapse
 9
Failure To Osseointegrate
 9
Device Operational Issue
 7
Component Falling
 7
Dent In Material
 7
Component Or Accessory Incompatibility
7
Out-Of-Box Failure
 7
Total Device Problems 39347
Recalls
Manufacturer Recall Class Date Posted
1
Aesculap Implant Systems
 II Jun-26-2015
2
Aesculap, Inc.
 II Mar-03-2016
3
Arthrex, Inc.
 II Mar-19-2016
4
Biomet, Inc.
 III Jun-11-2015
5
Biomet, Inc.
 II Aug-15-2014
6
ConforMIS, Inc.
 II Oct-02-2018
7
ConforMIS, Inc.
 II Feb-13-2018
8
ConforMIS, Inc.
 II Jan-10-2017
9
ConforMIS, Inc.
 II Nov-25-2016
10
ConforMIS, Inc.
 II Oct-21-2015
11
ConforMIS, Inc.
 II Dec-11-2014
12
Conformis, Inc.
 II Mar-30-2019
13
DePuy Orthopaedics, Inc.
 II Aug-29-2018
14
DePuy Orthopaedics, Inc.
 II Apr-30-2018
15
DePuy Orthopaedics, Inc.
 II Mar-13-2014
16
DePuy Orthopaedics, Inc.
 II Feb-24-2014
17
Encore Medical, Lp
 II Aug-31-2018
18
Encore Medical, Lp
 II Jan-10-2018
19
Encore Medical, Lp
 II Oct-20-2017
20
Encore Medical, Lp
 II Jun-30-2017
21
Encore Medical, Lp
 II Feb-03-2017
22
Encore Medical, Lp
 II Dec-14-2016
23
Encore Medical, Lp
 II Dec-06-2016
24
Encore Medical, Lp
 II Oct-28-2016
25
Exactech, Inc.
 II Sep-20-2018
26
Exactech, Inc.
 II Nov-20-2017
27
Exactech, Inc.
 II Jun-19-2017
28
Exactech, Inc.
 II Jan-05-2015
29
Materialise N.V.
 II Mar-17-2015
30
Materialise USA LLC
 II Jun-09-2016
31
Materialise USA LLC
 II Nov-21-2014
32
Medacta Usa Inc
 II Dec-20-2017
33
Medacta Usa Inc
 II Jun-26-2015
34
Medtronic Sofamor Danek USA Inc
 II Mar-21-2017
35
Medtronic Sofamor Danek USA Inc
 II Aug-23-2016
36
Microport Orthopedics INC.
 II Mar-06-2015
37
OMNIlife Science Inc.
 II Mar-19-2018
38
Ortho Development Corporation
 II Jun-26-2015
39
Ortho Development Corporation
 II Aug-17-2014
40
Ortho Development Corporation
 II May-13-2014
41
Signal Medical Corporation
 II Oct-22-2014
42
Signature Orthopedics Pty Limited
 II Feb-14-2019
43
Smith & Nephew, Inc.
 II Mar-22-2019
44
Smith & Nephew, Inc.
 II Oct-01-2018
45
Smith & Nephew, Inc.
 II Aug-22-2018
46
Smith & Nephew, Inc.
 II May-22-2018
47
Smith & Nephew, Inc.
 II Nov-16-2017
48
Smith & Nephew, Inc.
 II Jun-12-2017
49
Smith & Nephew, Inc.
 II Apr-21-2016
50
Smith & Nephew, Inc.
 II Feb-17-2016
51
Smith & Nephew, Inc.
 II Jan-04-2016
52
Smith & Nephew, Inc.
 II Dec-12-2014
53
Stanmore Implants Worldwide Ltd.
 II May-09-2016
54
Stelkast Co
 II Jan-14-2015
55
Stryker Howmedica Osteonics Corp.
 II Aug-09-2016
56
Stryker Howmedica Osteonics Corp.
 II Dec-02-2015
57
Stryker Howmedica Osteonics Corp.
 II Nov-09-2015
58
Stryker Howmedica Osteonics Corp.
 II Aug-10-2015
59
Stryker Howmedica Osteonics Corp.
 II May-19-2015
60
Stryker Howmedica Osteonics Corp.
 II May-14-2015
61
United Orthopedic Corporation
 II Mar-19-2018
62
Zimmer Biomet, Inc.
 II Feb-23-2019
63
Zimmer Biomet, Inc.
 II Dec-18-2018
64
Zimmer Biomet, Inc.
 II Nov-21-2018
65
Zimmer Biomet, Inc.
 II Sep-25-2018
66
Zimmer Biomet, Inc.
 II Jun-04-2018
67
Zimmer Biomet, Inc.
 II Jun-01-2018
68
Zimmer Biomet, Inc.
 II Jun-01-2018
69
Zimmer Biomet, Inc.
 II May-11-2018
70
Zimmer Biomet, Inc.
 II Mar-14-2018
71
Zimmer Biomet, Inc.
 II Feb-21-2018
72
Zimmer Biomet, Inc.
 II Feb-15-2018
73
Zimmer Biomet, Inc.
 II May-18-2017
74
Zimmer Biomet, Inc.
 II Mar-27-2017
75
Zimmer Biomet, Inc.
 II Feb-16-2017
76
Zimmer Biomet, Inc.
 II Jan-28-2017
77
Zimmer Biomet, Inc.
 II Oct-18-2016
78
Zimmer Biomet, Inc.
 II Oct-03-2016
79
Zimmer Biomet, Inc.
 II Feb-22-2016
80
Zimmer CAS
 II Dec-16-2014
81
Zimmer Manufacturing B.V.
 II Apr-06-2016
82
Zimmer Manufacturing B.V.
 II Mar-12-2016
83
Zimmer Manufacturing B.V.
 II Jan-05-2016
84
Zimmer Manufacturing B.V.
 II Dec-18-2015
85
Zimmer Trabecular Metal Technology, Inc.
 II Mar-11-2019
86
Zimmer, Inc.
 II Jul-01-2015
87
Zimmer, Inc.
 II May-01-2015
88
Zimmer, Inc.
 II Apr-01-2015
89
Zimmer, Inc.
 II Feb-03-2015
90
Zimmer, Inc.
 II Dec-23-2014
91
Zimmer, Inc.
 II Nov-08-2014
92
Zimmer, Inc.
 II Oct-23-2014
93
Zimmer, Inc.
 II Sep-04-2014
94
Zimmer, Inc.
 II Sep-04-2014
95
Zimmer, Inc.
 II Aug-26-2014
96
Zimmer, Inc.
 II Aug-21-2014
97
Zimmer, Inc.
 II Jun-27-2014
98
Zimmer, Inc.
 II Mar-20-2014
99
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:51:22
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.