Plate, Fixation, Bone

Device Code: 4461

Product Code(s): HRS

Device Classification Information

Device Type ID4461
Device NamePlate, Fixation, Bone
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 Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(k)
CFR Regulation Number888.3030 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHRS
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4461
DevicePlate, Fixation, Bone
Product CodeHRS
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.
CFR Regulation Number888.3030 [🔎]
Premarket Reviews
ManufacturerDecision
4WEB, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
AAP IMPLANTATE AG
 
SUBSTANTIALLY EQUIVALENT
 7
ACCUMED SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
ACUMED LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ADDITIVE ORTHOPAEDICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
ADVANCED ORTHOPAEDIC SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 7
ARTHROCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
ARTHROSURFACE, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
AUXEIN MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMEDICAL ENTERPRISES
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMEDICAL ENTERPRISES, INC
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMEDICAL ENTERPRISES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 10
BIOMET INC
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET MICROFIXATION
 
SUBSTANTIALLY EQUIVALENT
 6
BIOPRO, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CARBOFIX ORTHOPEDICS LTD.
 
SUBSTANTIALLY EQUIVALENT
 4
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD
 
SUBSTANTIALLY EQUIVALENT
 1
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD
 
SUBSTANTIALLY EQUIVALENT
 1
CITIEFFE S.R.L.
 
SUBSTANTIALLY EQUIVALENT
 1
CONVENTUS ORTHOPAEDICS
 
SUBSTANTIALLY EQUIVALENT
 1
CONVENTUS ORTHOPAEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CROSSROADS EXTREMITY SYSTEMS LLC
 
SUBSTANTIALLY EQUIVALENT
 3
DEPUY SYNTHES
 
SUBSTANTIALLY EQUIVALENT
 2
EMERGE MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 6
EMINENT SPINE
 
SUBSTANTIALLY EQUIVALENT
 1
EXTREMITY MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
EXTREMITY MEDICAL, LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
FLEXTRONICS INTERNATIONAL USA, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
FLOWER ORTHOPEDICS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
FX SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
GENESIS FRACTURE CARE, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 3
GPC MEDICAL LTD
 
SUBSTANTIALLY EQUIVALENT
 1
I.T.S. GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
IMPACT MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
IN2BONES SAS
 
SUBSTANTIALLY EQUIVALENT
 2
IN2BONES USA, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
JEIL MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 11
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 2
KLS MARTIN GMBH + CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
KLS MARTIN GMBH And CO. KG
 
SUBSTANTIALLY EQUIVALENT
 3
LAURA CATTABRIGA
 
SUBSTANTIALLY EQUIVALENT
 1
LIFE SPINE
 
SUBSTANTIALLY EQUIVALENT
 4
MBD MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDARTIS AG
 
SUBSTANTIALLY EQUIVALENT
 7
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
 2
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDLINE, INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MERETE MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
MERIL HEALTHCARE PVT. LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MIAMI DEVICE SOLUTIONS
 
SUBSTANTIALLY EQUIVALENT
 1
MICROWARE PRECISION CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
NARANG MEDICAL LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
NARANG MEDICAL USA CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
 
SUBSTANTIALLY EQUIVALENT
 1
NEWCLIP TECHNICS
 
SUBSTANTIALLY EQUIVALENT
 11
NEXTREMITY SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
NOVASTEP
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHO SOLUTIONS LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOHELIX SURGICAL DESIGN
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOPAEDIC IMPLANT COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOPEDIATRICS, CORP
 
SUBSTANTIALLY EQUIVALENT
 3
OSTEOMED
 
SUBSTANTIALLY EQUIVALENT
 3
OSTEOMED LP
 
SUBSTANTIALLY EQUIVALENT
 1
PARAGON 28
 
SUBSTANTIALLY EQUIVALENT
 2
PEGA MEDICAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SCIENCE FOR BIOMATERIALS
 
SUBSTANTIALLY EQUIVALENT
 1
SHOULDER OPTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SKELETAL DYNAMICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 5
SMITH & NEPHEW, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 14
SMV SCIENTIFIC
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 23
STRYKER LEIBINGER GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER TRAUMA AG
 
SUBSTANTIALLY EQUIVALENT
 10
STUCKENBROCK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
 
SUBSTANTIALLY EQUIVALENT
 3
SYNTHES USA
 
SUBSTANTIALLY EQUIVALENT
 1
TORNIER
 
SUBSTANTIALLY EQUIVALENT
 1
TORNIER INC.
 
SUBSTANTIALLY EQUIVALENT
 2
TREACE MEDICAL CONCEPTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
TRIMED, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
TRUEMED GROUP, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 15
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 2
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
 4
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 8
Device Problems
Adverse Event Without Identified Device Or Use Problem
 2744
Break
 1519
Fracture
 488
Migration Or Expulsion Of Device
316
Insufficient Information
 299
Device Operates Differently Than Expected
 164
Appropriate Term/Code Not Available
 135
Fitting Problem
 134
Screw
 110
Packaging Problem
 107
Migration
 94
Unintended Movement
 87
Device-Device Incompatibility
 81
Material Fragmentation
 75
Corroded
74
Physical Resistance / Sticking
 65
Device Inoperable
 59
Bent
 59
Difficult To Remove
53
Separation Failure
52
Difficult To Insert
 51
Manufacturing, Packaging Or Shipping Problem
 48
Device Dislodged Or Dislocated
 47
Mechanical Problem
 46
Loose Or Intermittent Connection
 43
Component Missing
43
Device Markings / Labelling Problem
 39
Detachment Of Device Or Device Component
 39
Plate
 39
Failure To Align
 37
Dull, Blunt
 37
Pin
 36
Device Slipped
 35
Material Discolored
 33
Failure To Adhere Or Bond
 32
Material Deformation
 32
Malposition Of Device
31
Patient-Device Incompatibility
 28
Delivered As Unsterile Product
 26
No Apparent Adverse Event
 25
Osseointegration Problem
 24
Use Of Device Problem
 22
Device Contamination With Chemical Or Other Material
 22
Material Twisted / Bent
 21
Inadequacy Of Device Shape And/or Size
 20
Device Contaminated During Manufacture Or Shipping
 19
Detachment Of Device Component
 19
Sharp Edges
 19
Failure To Osseointegrate
 19
Disassembly
 18
Positioning Problem
 17
Unsealed Device Packaging
 15
Screw Head
 15
Metal Shedding Debris
 14
Device Packaging Compromised
 14
Mechanical Jam
 14
Crack
 13
Improper Or Incorrect Procedure Or Method
 12
Tip
 11
Degraded
 10
Sticking
 9
Unstable
 8
Device Operational Issue
 8
Loosening Of Implant Not Related To Bone-Ingrowth
 7
Material Separation
 7
Difficult To Position
 7
Premature Activation
7
Noise, Audible
 7
Mechanics Altered
 7
Naturally Worn
 6
Component Or Accessory Incompatibility
6
Device Damaged By Another Device
 6
Peeled / Delaminated
 6
Loss Of Osseointegration
 6
Material Integrity Problem
 6
Connection Problem
 6
Wire
 6
Compatibility Problem
 5
Patient Device Interaction Problem
 5
Device Issue
 5
Off-Label Use
 5
Device Or Device Fragments Location Unknown
 5
Biocompatibility
5
Material Rupture
 5
Flaked
 4
Thread
 4
Missing Value Reason
 4
Incomplete Or Missing Packaging
 4
Device Handling Problem
 4
Unraveled Material
 4
Device Difficult To Maintain
 4
Misassembled
 4
Extrusion
 3
Device Difficult To Setup Or Prepare
 3
Deformation Due To Compressive Stress
3
Tear, Rip Or Hole In Device Packaging
 3
Failure To Advance
 3
Defective Device
 3
Device Expiration Issue
 3
Component Falling
 3
Total Device Problems 8006
Recalls
Manufacturer Recall Class Date Posted
1
ACUTE Innovations, LLC
 II Jan-28-2014
2
Acumed LLC
 II Feb-14-2017
3
Acumed LLC
 II Apr-25-2014
4
Arthrex, Inc.
 II Apr-08-2016
5
Biomet, Inc.
 II May-26-2016
6
Biomet, Inc.
 II Dec-18-2015
7
Biomet, Inc.
 II Jul-10-2015
8
Biomet, Inc.
 II Jul-08-2015
9
Biomet, Inc.
 II Aug-13-2014
10
Biomet, Inc.
 II Jan-10-2014
11
Epic Extremity, LLC
 II May-15-2018
12
In2Bones, SAS
 II Aug-03-2017
13
In2Bones, SAS
 II Jan-06-2017
14
Integra LifeSciences Corp.
 II Jun-14-2016
15
NewDeal SA
 II Jul-16-2018
16
OrthoPediatrics Corp
 II Sep-18-2015
17
Orthofix, Inc
 II Jun-07-2018
18
Smith & Nephew, Inc.
 II Jan-24-2018
19
Smith & Nephew, Inc.
 II Jan-19-2018
20
Smith & Nephew, Inc.
 II Apr-18-2017
21
Smith & Nephew, Inc.
 II Apr-14-2017
22
Smith & Nephew, Inc.
 II Dec-04-2015
23
Synthes (USA) Products LLC
 II Aug-11-2016
24
Synthes (USA) Products LLC
 II Jun-10-2016
25
Synthes (USA) Products LLC
 II Nov-06-2015
26
Synthes (USA) Products LLC
 II Oct-30-2015
27
Synthes (USA) Products LLC
 II Oct-15-2015
28
Synthes, Inc.
 II Mar-25-2014
29
Synthes, Inc.
 II Mar-11-2014
30
TriMed Inc.
 II Aug-18-2018
31
Trilliant Surgical Ltd.
 II Sep-04-2015
32
Trilliant Surgical Ltd.
 II Aug-31-2015
33
Trimed Inc
 II Sep-20-2016
34
Wright Medical Technology, Inc.
 II Sep-01-2015
35
Wright Medical Technology, Inc.
 II Apr-22-2015
36
Wright Medical Technology, Inc.
 II Sep-08-2014
37
Zimmer Biomet, Inc.
 II Aug-31-2018
38
Zimmer Biomet, Inc.
 II Apr-03-2018
39
Zimmer Biomet, Inc.
 II Jan-14-2016
40
Zimmer Manufacturing B.V.
 II Mar-12-2016
41
Zimmer, Inc.
 II Aug-26-2014
42
Zimmer, Inc.
 II Jul-30-2014
43
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:49:42
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