Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Device Code: 4551

Product Code(s): KRO

Device Classification Information

Device Type ID4551
Device NameProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Regulation DescriptionKnee Joint Femorotibial Metal/polymer 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 Number888.3510 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKRO
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4551
DeviceProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Product CodeKRO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionKnee Joint Femorotibial Metal/polymer Constrained Cemented Prosthesis.
CFR Regulation Number888.3510 [🔎]
Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 2
ONKOS SURGICAL
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STANMORE IMPLANTS WORLDWIDE LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
STANMORE INC.
 
SUBSTANTIALLY EQUIVALENT
 1
WALDEMAR LINK GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 3
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Insufficient Information
 576
Adverse Event Without Identified Device Or Use Problem
 427
Fracture
 178
Break
 130
Migration Or Expulsion Of Device
95
Device Dislodged Or Dislocated
 82
Detachment Of Device Or Device Component
 61
Unstable
 57
Naturally Worn
 56
Disassembly
 54
Loss Of Osseointegration
 40
Mechanical Problem
 38
Appropriate Term/Code Not Available
 36
Packaging Problem
 30
Loose Or Intermittent Connection
 26
Failure To Adhere Or Bond
 20
Device Operates Differently Than Expected
 20
Material Integrity Problem
 18
Detachment Of Device Component
 18
Noise, Audible
 16
Unintended Movement
 15
Migration
 15
Tear, Rip Or Hole In Device Packaging
 14
Component Missing
14
Degraded
 11
Incorrect Device Or Component Shipped
 11
Mechanical Jam
 11
Loosening Of Implant Not Related To Bone-Ingrowth
 11
Manufacturing, Packaging Or Shipping Problem
 11
Device Packaging Compromised
 9
Loss Of Or Failure To Bond
 9
Use Of Device Problem
 8
Device Issue
 8
Inadequacy Of Device Shape And/or Size
 8
Device Damaged Prior To Use
8
Difficult To Insert
 8
Material Erosion
 8
Device Markings / Labelling Problem
 7
Crack
 7
Improper Or Incorrect Procedure Or Method
 7
Patient-Device Incompatibility
 6
Metal Shedding Debris
 6
Delivered As Unsterile Product
 6
Malposition Of Device
6
Material Deformation
 6
Device Contaminated During Manufacture Or Shipping
 5
Fitting Problem
 5
Device Contamination With Chemical Or Other Material
 5
Out-Of-Box Failure
 5
Positioning Failure
5
Scratched Material
 5
Source, Incorrect
 5
Compatibility Problem
 4
Defective Component
 4
Label
 4
Shipping Damage Or Problem
 4
Component Or Accessory Incompatibility
4
Material Separation
 3
Incomplete Or Missing Packaging
 3
Device-Device Incompatibility
 3
Positioning Problem
 3
Disconnection
 3
Labelling, Instructions For Use Or Training Problem
 3
Screw
 3
Contamination / Decontamination Problem
3
Product Quality Problem
 3
Osseointegration Problem
 3
Pin
 2
Device Reprocessing Problem
 2
Device Operational Issue
 2
Activation Problem
2
Shelf Life Exceeded
 2
Device Slipped
 2
Inaccurate Delivery
2
Component Incompatible
 2
Unsealed Device Packaging
 2
Off-Label Use
 2
Device Damaged By Another Device
 2
Unclear Information
 2
Material Fragmentation
 1
Tube
 1
Spring
 1
Separation Failure
1
Locking Mechanism
 1
Misassembly By Users
 1
Device Handling Problem
 1
Patient Device Interaction Problem
 1
Biological Environmental Factor
 1
Contamination Of Device Ingredient Or Reagent
 1
Device Misassembled During Manufacturing / Shipping
 1
Physical Resistance / Sticking
 1
Incomplete Or Inadequate Connection
 1
Cut In Material
 1
Failure To Align
 1
Material Perforation
 1
No Device Output
1
Difficult To Position
 1
Separation Problem
1
Torn Material
 1
Entrapment Of Device
 1
Total Device Problems 2338
Recalls
Manufacturer Recall Class Date Posted
1
DePuy Orthopaedics, Inc.
 II Mar-13-2014
2
Medacta Usa
 II Nov-14-2015
3
Medacta Usa Inc
 II Jun-12-2017
4
Onkos Surgical, Inc.
 II Jun-29-2017
5
Smith & Nephew, Inc.
 II Mar-19-2018
6
Smith & Nephew, Inc.
 II Jun-29-2016
7
Stanmore Implants Worldwide Ltd.
 II Sep-05-2017
8
Stanmore Implants Worldwide Ltd.
 II Dec-19-2016
9
Stanmore Implants Worldwide Ltd.
 II Aug-17-2016
10
Zimmer Biomet, Inc.
 II Dec-07-2018
11
Zimmer Biomet, Inc.
 II Feb-26-2018
12
Zimmer Biomet, Inc.
 II Dec-29-2017
13
Zimmer Biomet, Inc.
 II Nov-08-2017
14
Zimmer Biomet, Inc.
 II Mar-20-2017
15
Zimmer Biomet, Inc.
 II Jan-28-2017
16
Zimmer, Inc.
 II Mar-20-2014
17
Zimmer, Inc.
 II Jan-17-2014
TPLC Last Update: 2019-04-02 20:51:32
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