Screw, Fixation, Bone

Device Code: 4489

Product Code(s): HWC

Device Classification Information

Device Type ID4489
Device NameScrew, Fixation, Bone
Regulation DescriptionSmooth Or Threaded Metallic Bone Fixation Fastener.
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 Number888.3040 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHWC
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4489
DeviceScrew, Fixation, Bone
Product CodeHWC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSmooth Or Threaded Metallic Bone Fixation Fastener.
CFR Regulation Number888.3040 [🔎]
Premarket Reviews
ManufacturerDecision
AAP IMPLANTATE AG
 
SUBSTANTIALLY EQUIVALENT
 2
AESCULAP IMPLANT SYSTEM, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
AGENT MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
ARTHROCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 3
ARTHROSURFACE, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
ASCENSION ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ASCENT MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
BIEDERMANN MEDTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 6
BIOMET INC
 
SUBSTANTIALLY EQUIVALENT
 2
BIOMET MICROFIXATION
 
SUBSTANTIALLY EQUIVALENT
 1
CARTIVA, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
COMPETITIVE ENGINEERING INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CONMED
 
SUBSTANTIALLY EQUIVALENT
 1
CONMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
CROSSROADS EXTREMITY SYSTEMS LLC
 
SUBSTANTIALLY EQUIVALENT
 3
ENGINEERING CONSULTING SERVICES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EXSOMED HOLDING COMPANY, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
EXTREMITY MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
EXTREMITY MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
EXTREMITY MEDICAL, LLC.
 
SUBSTANTIALLY EQUIVALENT
 2
FEET FOR LIFE PODIATRY CENTER
 
SUBSTANTIALLY EQUIVALENT
 1
FIRST RAY LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FLOWER ORTHOPEDICS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
FLOW-FX, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FOURNITURES HOSPITALIERES
 
SUBSTANTIALLY EQUIVALENT
 3
FOURNITURES HOSPITALIERES INDUSTRIE
 
SUBSTANTIALLY EQUIVALENT
 3
FUSION ORTHOPEDICS, LLC.
 
SUBSTANTIALLY EQUIVALENT
 4
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ICONN ORTHOPEDICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
IN2BONES SAS
 
SUBSTANTIALLY EQUIVALENT
 6
IN2BONES USA, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
INFIX MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
KLS MARTIN GMBH And CO. KG
 
SUBSTANTIALLY EQUIVALENT
 1
LAURA CATTABRIGA
 
SUBSTANTIALLY EQUIVALENT
 1
LIFE SPINE
 
SUBSTANTIALLY EQUIVALENT
 4
MEDLINE
 
SUBSTANTIALLY EQUIVALENT
 1
MEDLINE INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDSHAPE, INC
 
SUBSTANTIALLY EQUIVALENT
 1
MEDSHAPE, INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
MEMPHIS ORTHOPAEDIC DESIGN, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MERETE MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 3
MTP SOLUTIONS LLC
 
SUBSTANTIALLY EQUIVALENT
 2
MX ORTHOPEDICS CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
 
SUBSTANTIALLY EQUIVALENT
 1
NEOSTEO
 
SUBSTANTIALLY EQUIVALENT
 2
NEWCLIP TECHNICS
 
SUBSTANTIALLY EQUIVALENT
 3
NEXTREMITY SOLUTIONS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
NORMED NEDIZIN TECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
NOVASTEP
 
SUBSTANTIALLY EQUIVALENT
 2
NVISION BIOMEDICAL TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
ORTHOFIX
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOFIX SRL
 
SUBSTANTIALLY EQUIVALENT
 1
OSTEOMED
 
SUBSTANTIALLY EQUIVALENT
 2
OVERMED SRL.
 
SUBSTANTIALLY EQUIVALENT
 1
PARAGON 28
 
SUBSTANTIALLY EQUIVALENT
 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SAFETYFIX MEDICAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SIGN FRACTURE CARE INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 1
SKELETAL DYNAMICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SMV SCIENTIFIC
 
SUBSTANTIALLY EQUIVALENT
 4
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
STRYKER TRAUMA AG
 
SUBSTANTIALLY EQUIVALENT
 2
STUCKENBROCK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
SYNCHRO MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
SYNTHES USA PRODUCTS, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
TORNIER
 
SUBSTANTIALLY EQUIVALENT
 1
TORNIER INC.
 
SUBSTANTIALLY EQUIVALENT
 1
TREACE MEDICAL CONCEPTS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
TYBER MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 4
TYBER MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
VILEX IN TENNESSEE, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 15
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
Device Problems
Adverse Event Without Identified Device Or Use Problem
 3511
Break
 2147
Fracture
 432
Insufficient Information
 408
Migration Or Expulsion Of Device
342
Unintended Movement
 303
Material Fragmentation
 282
Migration
 202
Device-Device Incompatibility
 143
Appropriate Term/Code Not Available
 142
Device Operates Differently Than Expected
 140
Material Twisted / Bent
 128
Corroded
107
Loose Or Intermittent Connection
 104
Loss Of Osseointegration
 81
Difficult To Remove
74
Device Dislodged Or Dislocated
 68
Screw
 65
Bent
 64
Failure To Align
 63
Material Deformation
 59
Fitting Problem
 53
Malposition Of Device
50
Use Of Device Problem
 48
Improper Or Incorrect Procedure Or Method
 41
Mechanical Problem
 41
Device Slipped
 37
Failure To Adhere Or Bond
 37
Crack
 33
Detachment Of Device Or Device Component
 32
Mechanical Jam
 32
Dull, Blunt
 30
No Apparent Adverse Event
 30
Difficult To Insert
 29
Packaging Problem
 26
Detachment Of Device Component
 26
Material Frayed
 25
Component Missing
23
Device Markings / Labelling Problem
 22
Positioning Problem
 21
Separation Failure
20
Noise, Audible
 18
Material Discolored
 18
Patient-Device Incompatibility
 18
Manufacturing, Packaging Or Shipping Problem
 17
Component Incompatible
 17
Metal Shedding Debris
 16
Difficult To Advance
 14
Naturally Worn
 14
Biocompatibility
13
Peeled / Delaminated
 13
Sticking
 13
Failure To Advance
 13
Inadequacy Of Device Shape And/or Size
 12
Difficult To Position
 11
Activation, Positioning Or Separation Problem
 11
Tip
 10
Positioning Failure
10
Material Separation
 10
Loosening Of Implant Not Related To Bone-Ingrowth
 10
Entrapment Of Device
 9
Flaked
 9
Degraded
 9
Material Split, Cut Or Torn
 8
Material Integrity Problem
 8
Defective Device
 8
Plate
 7
Incomplete Or Missing Packaging
 7
Unstable
 7
Unknown (for Use When The Device Problem Is Not Known)
 7
Component Or Accessory Incompatibility
6
Device Packaging Compromised
 6
Device Contamination With Chemical Or Other Material
 6
Loss Of Or Failure To Bond
 5
Extrusion
 5
Device Inoperable
 5
Failure To Osseointegrate
 5
Device Operational Issue
 4
Screw Head
 4
Biofilm Coating In Device
4
Retraction Problem
 4
Disassembly
 4
Failure To Cut
 4
Device Expiration Issue
 4
Collapse
 4
Missing Value Reason
 4
Material Erosion
 4
Material Distortion
 4
Mechanics Altered
 3
Material Rupture
 3
Device Damaged Prior To Use
3
Shelf Life Exceeded
 3
Device Damaged By Another Device
 3
Patient Device Interaction Problem
 3
Out-Of-Box Failure
 3
Unsealed Device Packaging
 3
Unintended Ejection
3
Unraveled Material
 3
Bolt
 3
Suture
 2
Total Device Problems 9975
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II May-26-2016
2
Biomet, Inc.
 II Jul-01-2015
3
Cayenne Medical Inc.
 II Jul-10-2018
4
DePuy Mitek, Inc., A Johnson & Johnson Co.
 II Jun-20-2017
5
Flower Orthopedics Corporation
 II Mar-24-2015
6
In2Bones, SAS
 II Dec-09-2015
7
In2Bones, SAS
 II Mar-25-2015
8
In2bones USA, LLC
 II Aug-21-2018
9
Instratek, Incorporated
 II Sep-22-2014
10
Integra LifeSciences Corp.
 II Aug-19-2016
11
Integra LifeSciences Corporation
 II Jun-02-2014
12
Medartis, Inc.
 II Oct-30-2014
13
MicroAire Surgical Instruments, LLC
 II Jul-27-2016
14
MicroPort Orthopedics Inc.
 II Oct-11-2018
15
ORTHO SOLUTIONS, LTD.
 II Mar-09-2018
16
Ortho Solutions Inc
 II Sep-16-2016
17
Ortho Solutions Inc
 II Oct-06-2015
18
OrthoPediatrics Corp
 II Sep-19-2016
19
OrthoPediatrics Corp
 II Feb-06-2014
20
Pega Medical Inc.
 II Nov-20-2015
21
Pega Medical Inc.
 II Jun-26-2015
22
Small Bone Innovations
 II Jul-30-2014
23
Smith & Nephew, Inc.
 II Mar-20-2018
24
Smith & Nephew, Inc.
 II Apr-18-2017
25
Stryker Corporation
 II Mar-02-2018
26
Stryker Howmedica Osteonics Corp.
 II Apr-18-2016
27
Synthes (USA) Products LLC
 II Oct-24-2018
28
Synthes (USA) Products LLC
 II Jul-11-2016
29
Synthes (USA) Products LLC
 II Apr-27-2016
30
Synthes (USA) Products LLC
 II Nov-20-2015
31
Synthes (USA) Products LLC
 II Sep-18-2015
32
Synthes, Inc.
 II Jun-15-2015
33
Synthes, Inc.
 II Aug-19-2014
34
Synthes, Inc.
 II Jul-02-2014
35
Trilliant Surgical Ltd.
 II Jan-06-2017
36
Trilliant Surgical Ltd.
 II Nov-17-2016
37
Trilliant Surgical Ltd.
 II Aug-26-2015
38
Trilliant Surgical Ltd.
 II Aug-19-2015
39
Wright Medical Technology, Inc.
 II May-18-2015
40
Zimmer Biomet, Inc.
 II Sep-14-2018
41
Zimmer Biomet, Inc.
 II May-08-2018
42
Zimmer Biomet, Inc.
 II Mar-15-2018
43
Zimmer Biomet, Inc.
 II Feb-16-2017
44
Zimmer Biomet, Inc.
 II Jan-13-2016
45
Zimmer Manufacturing B.V.
 II May-16-2016
46
Zimmer Manufacturing B.V.
 II Mar-12-2016
47
Zimmer Manufacturing B.V.
 II Jul-10-2014
48
Zimmer, Inc.
 II Aug-26-2014
49
Zimmer, Inc.
 II Aug-16-2014
50
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:50:24
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