Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Device Code: 4556

Product Code(s): KTT

Device Classification Information

Device Type ID4556
Device NameAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Regulation DescriptionSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.
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 Number888.3030 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKTT
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4556
DeviceAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Product CodeKTT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.
CFR Regulation Number888.3030 [🔎]
Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPAEDIC SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ASCENSION ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CARDINAL HEALTH
 
SUBSTANTIALLY EQUIVALENT
 1
CARDINAL HEALTH 200, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
CITIEFFE S.R.L.
 
SUBSTANTIALLY EQUIVALENT
 1
D.N.E., LLC
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY SYNTHES
 
SUBSTANTIALLY EQUIVALENT
 1
DEVISE ORTHO, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA LIFESCIENCES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
JEIL MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
LIFE SPINE
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOFIX
 
SUBSTANTIALLY EQUIVALENT
 8
ORTHOFIX SRL
 
SUBSTANTIALLY EQUIVALENT
 8
ORTHOPAEDIC IMPLANT COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
PEGA MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 6
STRYKER TRAUMA AG
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES (USA) HQ LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
 
SUBSTANTIALLY EQUIVALENT
 1
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
Device Problems
Adverse Event Without Identified Device Or Use Problem
 595
Break
 300
Mechanical Problem
 161
Unintended Movement
 95
Fracture
 46
Device Operates Differently Than Expected
 46
Migration
 44
Insufficient Information
 38
Fitting Problem
 34
Device-Device Incompatibility
 34
Material Deformation
 26
Migration Or Expulsion Of Device
26
Difficult To Remove
19
Device Slipped
 19
Mechanical Jam
 16
Appropriate Term/Code Not Available
 15
Contamination / Decontamination Problem
14
Failure To Align
 14
Bent
 13
Patient Device Interaction Problem
 12
Screw
 9
Failure To Adhere Or Bond
 8
Material Fragmentation
 8
Peeled / Delaminated
 7
Crack
 7
Loose Or Intermittent Connection
 7
Material Twisted / Bent
 7
Use Of Device Problem
 7
Device Dislodged Or Dislocated
 5
No Apparent Adverse Event
 5
Detachment Of Device Or Device Component
 5
Sticking
 5
Difficult To Insert
 4
Malposition Of Device
4
Device Difficult To Maintain
 4
Metal Shedding Debris
 3
Component Missing
3
Particulates
 3
Corroded
3
Pin
 3
Material Integrity Problem
 3
Computer Software Problem
 3
Dull, Blunt
 3
Plate
 3
Component Incompatible
 2
Material Separation
 2
Detachment Of Device Component
 2
Device Damaged Prior To Use
2
Difficult To Advance
 2
Material Distortion
 2
Positioning Problem
 2
Device Expiration Issue
 2
Failure To Advance
 2
Bolt
 2
Device Operational Issue
 2
Material Disintegration
 1
Patient-Device Incompatibility
 1
Compatibility Problem
 1
Frame
 1
Material Discolored
 1
Product Quality Problem
 1
Device Inoperable
 1
Improper Or Incorrect Procedure Or Method
 1
Tear, Rip Or Hole In Device Packaging
 1
Material Puncture / Hole
 1
Shipping Damage Or Problem
 1
Difficult To Open Or Close
 1
Screw Head
 1
Delivered As Unsterile Product
 1
Unraveled Material
 1
Shelf Life Exceeded
 1
Naturally Worn
 1
Thread
 1
Adapter (Adaptor)
 1
Mechanics Altered
 1
Device Markings / Labelling Problem
 1
Material Rupture
 1
Material Erosion
 1
Hinge
 1
Partial Blockage
 1
Inadequacy Of Device Shape And/or Size
 1
Incorrect Device Or Component Shipped
 1
Device Contaminated During Manufacture Or Shipping
 1
Material Torqued
 1
Material Too Rigid Or Stiff
 1
Clamp
 1
Total Device Problems 1739
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II May-26-2016
2
Biomet, Inc.
 II Jun-09-2015
3
Integra LifeSciences Corp.
 II Aug-11-2016
4
Integra LifeSciences Corp.
 II Jul-27-2016
5
Orthofix Srl
 II Jun-05-2018
6
Orthofix Srl
 II Dec-27-2017
7
Small Bone Innovations, Inc.
 II Jun-04-2014
8
Stryker GmbH
 II Oct-29-2018
9
Stryker GmbH
 II Sep-22-2018
10
Stryker GmbH
 II Apr-26-2018
11
Stryker Howmedica Osteonics Corp.
 II May-25-2017
12
Synthes (USA) Products LLC
 II Aug-24-2015
13
Synthes, Inc.
 II Jun-19-2014
14
Zimmer Biomet, Inc.
 II Jun-15-2017
15
Zimmer Manufacturing B.V.
 II May-16-2016
16
Zimmer Manufacturing B.V.
 II Mar-12-2016
17
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:51:36
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