Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Device Code: 4577

Product Code(s): KWS

Device Classification Information

Device Type ID4577
Device NameProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Regulation DescriptionShoulder Joint 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 Number888.3660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWS
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4577
DeviceProsthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Product CodeKWS
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionShoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis.
CFR Regulation Number888.3660 [🔎]
Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
ASCENSION ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ASTON MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
CUSTOM ORTHOPAEDIC SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
DEPUY SYNTHES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
DJO GLOBAL
 
SUBSTANTIALLY EQUIVALENT
 1
ENCORE MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
ENCORE MEDICAL, L.P.
 
SUBSTANTIALLY EQUIVALENT
 3
EXACTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
LIMACORPORATE S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 4
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 1
OSTEOREMEDIES LLC
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
STRYKER TRAUMA AG
 
SUBSTANTIALLY EQUIVALENT
 1
TORNIER
 
SUBSTANTIALLY EQUIVALENT
 4
TORNIER INC.
 
SUBSTANTIALLY EQUIVALENT
 11
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
Device Problems
Insufficient Information
 958
Adverse Event Without Identified Device Or Use Problem
 766
Device Dislodged Or Dislocated
 524
Migration Or Expulsion Of Device
187
Fracture
 173
Unstable
 160
Difficult To Insert
 107
Loss Of Osseointegration
 82
Appropriate Term/Code Not Available
 77
Break
 75
Loss Of Or Failure To Bond
 69
Naturally Worn
 66
Disassembly
 60
Loose Or Intermittent Connection
 59
Device Operates Differently Than Expected
 47
Mechanical Problem
 40
Detachment Of Device Or Device Component
 39
Detachment Of Device Component
 39
Loosening Of Implant Not Related To Bone-Ingrowth
 38
Missing Value Reason
 30
Malposition Of Device
30
Bent
 30
Fitting Problem
 27
Noise, Audible
 26
Migration
 26
Device Slipped
 23
Material Separation
 21
Difficult To Position
 20
Material Integrity Problem
 20
Material Erosion
 17
Inadequacy Of Device Shape And/or Size
 16
Material Deformation
 15
Device Damaged By Another Device
 15
Device Contaminated During Manufacture Or Shipping
 13
Device-Device Incompatibility
 13
Disconnection
 12
Positioning Problem
 12
Osseointegration Problem
 12
Failure To Adhere Or Bond
 11
Unintended System Motion
 10
Packaging Problem
 10
Device Issue
 10
Mechanical Jam
 9
Screw
 9
Degraded
 7
Use Of Device Problem
 7
Improper Or Incorrect Procedure Or Method
 7
Scratched Material
 7
Dull, Blunt
 6
Torn Material
 6
Plate
 6
Difficult To Remove
6
Failure To Osseointegrate
 6
Device Abrasion From Instrument Or Another Object
 6
Cuff
 6
Connection Problem
 5
No Apparent Adverse Event
 5
Patient-Device Incompatibility
 5
Human-Device Interface Problem
 5
Material Twisted / Bent
 4
Pitted
 4
Material Fragmentation
 4
Component Or Accessory Incompatibility
4
Defective Device
 4
Crack
 3
Separation Problem
3
Material Distortion
 3
Patient Device Interaction Problem
 3
Device Packaging Compromised
 3
Positioning Failure
3
Unsealed Device Packaging
 3
Device Operational Issue
 3
Guidewire
 3
Device Difficult To Setup Or Prepare
 3
Component Missing
3
Tip
 2
Metal Shedding Debris
 2
Defective Component
 2
Failure To Advance
 2
Compatibility Problem
 2
Device Inoperable
 2
Device Reprocessing Problem
 2
Material Disintegration
 2
Off-Label Use
 2
Incomplete Or Missing Packaging
 2
Separation Failure
2
Unintended Movement
 2
Physical Resistance / Sticking
 2
Unintended Collision
 2
Difficult To Advance
 2
Entrapment Of Device
 2
Component Falling
 2
Housing
 1
Material Rupture
 1
Manufacturing, Packaging Or Shipping Problem
 1
Mechanics Altered
 1
Adapter (Adaptor)
 1
Failure To Align
 1
Device Contamination With Chemical Or Other Material
 1
Incorrect Device Or Component Shipped
 1
Total Device Problems 4188
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II Feb-24-2015
2
DePuy Orthopaedics, Inc.
 II Mar-01-2018
3
DePuy Orthopaedics, Inc.
 II Feb-27-2018
4
Encore Medical, Lp
 II Mar-28-2018
5
Exactech, Inc.
 II Jan-18-2018
6
Exactech, Inc.
 II Apr-20-2015
7
Integra LifeSciences Corp.
 II Nov-08-2014
8
Limacorporate S.p.A
 II May-25-2016
9
Stryker Howmedica Osteonics Corp.
 II Aug-10-2015
10
Tornier, Inc
 II Dec-03-2016
11
Zimmer Biomet, Inc.
 II Mar-01-2019
12
Zimmer Biomet, Inc.
 II Jun-01-2017
13
Zimmer Biomet, Inc.
 II Mar-27-2017
14
Zimmer Gmbh
 II Jun-16-2016
TPLC Last Update: 2019-04-02 20:52:05
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