Rod, Fixation, Intramedullary And Accessories

Device Code: 4467

Product Code(s): HSB

Device Classification Information

Device Type ID4467
Device NameRod, Fixation, Intramedullary And Accessories
Regulation DescriptionIntramedullary Fixation Rod.
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 Number888.3020 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHSB
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4467
DeviceRod, Fixation, Intramedullary And Accessories
Product CodeHSB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntramedullary Fixation Rod.
CFR Regulation Number888.3020 [🔎]
Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ADVANCED ORTHOPAEDIC SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 2
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOPRO, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CARBOFIX ORTHOPEDICS LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
CARDINAL HEALTH
 
SUBSTANTIALLY EQUIVALENT
 1
CARDINAL HEALTH 200, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CITIEFFE S.R.L.
 
SUBSTANTIALLY EQUIVALENT
 1
DGIMED ORTHO, INC
 
SUBSTANTIALLY EQUIVALENT
 1
DOUBLE MEDICAL TECHNOLOGY INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ELLIPSE TECHNOLOGIES INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ELLIPSE TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
EMERGE MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
EPIX ORTHOPAEDIC, CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
FLOW-FX, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FOURNITURES HOSPITALIERES
 
SUBSTANTIALLY EQUIVALENT
 2
FOURNITURES HOSPITALIERES INDUSTRIE
 
SUBSTANTIALLY EQUIVALENT
 2
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 1
I.T.S. GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
IN2BONES SAS
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRA LIFESCIENCES CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
INTRAFUSE LLC
 
SUBSTANTIALLY EQUIVALENT
 2
MEDSHAPE, INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
MERETE MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
NEOORTHO PRODUTOS ORTOPEDICOS S/A
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOFIX
 
SUBSTANTIALLY EQUIVALENT
 4
ORTHOFIX SRL
 
SUBSTANTIALLY EQUIVALENT
 4
ORTHOPAEDIC IMPLANT COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
PEGA MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 2
RENOVO LIFE LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SIGN FRACTURE CARE INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 2
SMITH & NEPHEW
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
SONOMA ORTHOPEDIC PRODUCTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
SYNTEC SCIENTIFIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
 
SUBSTANTIALLY EQUIVALENT
 4
THE ORTHOPEDIC IMPLANT COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
TRUEMED GROUP LLC
 
SUBSTANTIALLY EQUIVALENT
 1
TRUEMED GROUP, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
WITTENSTEIN INTENS GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
Device Problems
Adverse Event Without Identified Device Or Use Problem
 1523
Break
 1197
Migration Or Expulsion Of Device
312
Device Operates Differently Than Expected
 304
Fracture
 299
Device Contaminated During Manufacture Or Shipping
 259
Device-Device Incompatibility
 222
Packaging Problem
 217
Failure To Align
 210
Unintended Movement
 195
Delivered As Unsterile Product
 168
Insufficient Information
 145
Fitting Problem
 130
Mechanical Jam
 112
Migration
 83
Appropriate Term/Code Not Available
 75
Device Handling Problem
 57
Difficult To Insert
 55
Material Discolored
 55
Device Packaging Compromised
 52
Difficult To Remove
49
Mechanical Problem
 42
Screw
 36
Unsealed Device Packaging
 31
Sticking
 31
Material Fragmentation
 30
Bent
 29
Failure To Adhere Or Bond
 29
Malposition Of Device
25
Contamination / Decontamination Problem
24
Nonstandard Device
 22
Material Deformation
 22
Use Of Device Problem
 21
Tear, Rip Or Hole In Device Packaging
 19
Material Twisted / Bent
 18
Failure To Advance
 16
Crack
 16
Difficult To Advance
 16
Difficult To Position
 15
Detachment Of Device Component
 15
Disassembly
 15
Detachment Of Device Or Device Component
 14
Positioning Problem
 13
Device Markings / Labelling Problem
 12
Improper Or Incorrect Procedure Or Method
 12
Activation Failure Including Expansion Failures
11
Component Missing
10
Material Integrity Problem
 10
Inflation Problem
 10
Loose Or Intermittent Connection
 10
Device Contamination With Chemical Or Other Material
 10
Out-Of-Box Failure
 10
Incomplete Or Missing Packaging
 9
Device Damaged By Another Device
 9
Device Dislodged Or Dislocated
 9
Tip
 9
Connection Problem
 7
Corroded
7
Positioning Failure
7
Inadequacy Of Device Shape And/or Size
 7
Noise, Audible
 7
Off-Label Use
 6
Device Operational Issue
 6
Device Difficult To Maintain
 6
Misassembled
 5
Loss Of Or Failure To Bond
 5
Device Slipped
 5
Entrapment Of Device
 5
Failure To Disconnect
 4
Device Disinfection Or Sterilization Issue
 4
Device Expiration Issue
 4
Naturally Worn
 4
Separation Failure
4
Patient Device Interaction Problem
 4
Activation, Positioning Or Separation Problem
 4
Compatibility Problem
 4
Unstable
 3
Patient-Device Incompatibility
 3
Metal Shedding Debris
 3
No Apparent Adverse Event
 3
Misassembly By Users
 3
Material Separation
 3
Torn Material
 3
Thread
 3
Collapse
 3
Material Distortion
 3
Mechanics Altered
 3
Device Damaged Prior To Use
3
Dull, Blunt
 3
Material Erosion
 2
Flaked
 2
Manufacturing, Packaging Or Shipping Problem
 2
Biocompatibility
2
Defective Device
 2
Shelf Life Exceeded
 2
Inadequate Instructions For Non-Healthcare Professional
 2
Knife
 2
Tube
 2
Ring
 2
Component Incompatible
 2
Total Device Problems 6515
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II May-26-2016
2
CarboFix Orthopedics, Ltd.
 II Jun-14-2016
3
Integra LifeSciences Corp.
 II Mar-23-2017
4
Medacta Usa
 II Nov-12-2014
5
Ortho Solutions Inc
 II Jul-28-2017
6
OrthoPediatrics Corp
 III Dec-22-2016
7
Pega Medical Inc.
 II Apr-29-2015
8
Pega Medical Inc.
 II Apr-02-2015
9
Pega Medical Inc.
 II Apr-18-2014
10
Pega Medical Inc.
 II Apr-10-2014
11
Stryker GmbH
 II Aug-22-2018
12
Stryker GmbH
 II Jul-10-2018
13
Stryker Howmedica Osteonics Corp.
 II Sep-13-2016
14
Stryker Howmedica Osteonics Corp.
 II Feb-25-2016
15
Stryker Howmedica Osteonics Corp.
 II Oct-14-2014
16
Stryker Howmedica Osteonics Corp.
 II Jan-28-2014
17
Synthes (USA) Products LLC
 II Feb-13-2018
18
Synthes (USA) Products LLC
 II Nov-19-2016
19
Synthes (USA) Products LLC
 II Dec-04-2015
20
Synthes (USA) Products LLC
 II Oct-15-2015
21
Synthes (USA) Products LLC
 II Jul-16-2015
22
Synthes, Inc.
 II Jun-26-2015
23
Synthes, Inc.
 II May-12-2015
24
Synthes, Inc.
 II Mar-30-2015
25
Synthes, Inc.
 II Nov-14-2014
26
Tornier, Inc
 II Jul-29-2015
27
Vilex In Tennessee Inc
 II Jun-08-2015
28
Wright Medical Technology, Inc.
 II Apr-13-2018
29
Zimmer Biomet, Inc.
 II Nov-14-2018
30
Zimmer Biomet, Inc.
 II Oct-18-2018
31
Zimmer Biomet, Inc.
 II Sep-25-2018
32
Zimmer Biomet, Inc.
 II Sep-13-2018
33
Zimmer Biomet, Inc.
 II Apr-25-2018
34
Zimmer Biomet, Inc.
 II Apr-20-2018
35
Zimmer Biomet, Inc.
 II Mar-27-2018
36
Zimmer Biomet, Inc.
 II Mar-14-2018
37
Zimmer Biomet, Inc.
 II Mar-14-2018
38
Zimmer Biomet, Inc.
 II Jan-29-2018
39
Zimmer Biomet, Inc.
 II Jun-15-2017
40
Zimmer Biomet, Inc.
 II Jun-01-2017
41
Zimmer Biomet, Inc.
 II Mar-20-2017
42
Zimmer Gmbh
 II Oct-14-2015
43
Zimmer Manufacturing B.V.
 II May-16-2016
44
Zimmer Manufacturing B.V.
 II Mar-12-2016
45
Zimmer, Inc.
 II Jul-13-2015
46
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:49:54
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