Fastener, Fixation, Nondegradable, Soft Tissue

Device Code: 4617

Product Code(s): MBI

Device Classification Information

Device Type ID4617
Device NameFastener, Fixation, Nondegradable, Soft Tissue
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)
Restorative And Repair Devices Branch (RRDB)
Submission Type510(k)
CFR Regulation Number888.3040 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMBI
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4617
DeviceFastener, Fixation, Nondegradable, Soft Tissue
Product CodeMBI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSmooth Or Threaded Metallic Bone Fixation Fastener.
CFR Regulation Number888.3040 [🔎]
Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
AMENDIA INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHOCARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 11
ARTHROCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 9
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 5
BIOMET INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CAYENNE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 6
CONMED
 
SUBSTANTIALLY EQUIVALENT
 9
CONMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 9
COUSIN BIOTECH S.A.S.
 
SUBSTANTIALLY EQUIVALENT
 1
CROSSROADS EXTREMITY SYSTEMS LLC
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY INTL., LTD.
 
SUBSTANTIALLY EQUIVALENT
 2
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
EXTREMITY MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
FIRST RAY LLC
 
SUBSTANTIALLY EQUIVALENT
 1
ICONN ORTHOPEDICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 4
KATOR LLC
 
SUBSTANTIALLY EQUIVALENT
 3
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 1
MEDOS INTERNATIONAL SARL
 
SUBSTANTIALLY EQUIVALENT
 4
MORTISE MEDICAL LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MTP SOLUTIONS LLC
 
SUBSTANTIALLY EQUIVALENT
 2
NCS LAB SRL
 
SUBSTANTIALLY EQUIVALENT
 1
PARCUS MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 4
PIVOT MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
PONTIS ORTHOPAEDICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
PONTIS ORTHOPAEEICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
RIVERPOINT MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 2
SMITH & NEPHEW, INC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 11
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 6
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 7
SUMMIT MEDICAL LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
THE ORTHOPEDIC IMPLANT COMPANY
 
SUBSTANTIALLY EQUIVALENT
 1
TORNIER
 
SUBSTANTIALLY EQUIVALENT
 2
TORNIER INC.
 
SUBSTANTIALLY EQUIVALENT
 2
U & I CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
XIROS LTD
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Break
 247
Migration Or Expulsion Of Device
179
Adverse Event Without Identified Device Or Use Problem
 155
Fracture
 151
Activation, Positioning Or Separation Problem
 91
Insufficient Information
 91
Positioning Failure
82
Bent
 45
Detachment Of Device Component
 29
Device-Device Incompatibility
 28
Material Frayed
 28
Material Twisted / Bent
 25
Tip
 24
Material Split, Cut Or Torn
 22
Device Operates Differently Than Expected
 21
Material Fragmentation
 20
Difficult To Insert
 20
Positioning Problem
 18
Mechanical Jam
 18
Migration
 18
Failure To Advance
 17
Expulsion
 16
Detachment Of Device Or Device Component
 16
Appropriate Term/Code Not Available
 14
Disassembly
 13
Premature Activation
11
Loose Or Intermittent Connection
 10
Difficult To Advance
 10
Separation Failure
10
Device Contamination With Chemical Or Other Material
 10
Material Deformation
 10
Device Dislodged Or Dislocated
 10
Suture
 9
Device Markings / Labelling Problem
 9
Crack
 9
Difficult To Position
 8
Unintended Movement
 8
Unsealed Device Packaging
 8
Loosening Of Implant Not Related To Bone-Ingrowth
 8
Material Separation
 7
Device Contaminated During Manufacture Or Shipping
 7
Mechanical Problem
 7
Packaging Problem
 7
Difficult To Remove
7
Component Missing
7
Unknown (for Use When The Device Problem Is Not Known)
 6
Device Slipped
 6
Device Damaged Prior To Use
6
Device Packaging Compromised
 6
Device Difficult To Setup Or Prepare
 5
Misfire
5
Failure To Fire
5
Patient-Device Incompatibility
 4
Misassembled
 4
Difficult Or Delayed Positioning
 4
Loss Of Or Failure To Bond
 4
Deformation Due To Compressive Stress
4
Activation Problem
4
Device Misassembled During Manufacturing / Shipping
 4
Separation Problem
4
Fitting Problem
 3
Component Or Accessory Incompatibility
3
Device Damaged By Another Device
 3
Retraction Problem
 3
Use Of Device Problem
 3
Screw
 3
Component Misassembled
 3
Delivered As Unsterile Product
 3
Wire
 3
Device Operational Issue
 3
Improper Or Incorrect Procedure Or Method
 3
Material Integrity Problem
 2
Metal Shedding Debris
 2
Deflation Problem
 2
Failure To Eject
2
Material Protrusion / Extrusion
 2
Guide
 2
Sticking
 2
Device Subassembly
 2
Cut In Material
 2
Device Or Device Fragments Location Unknown
 2
Torn Material
 2
Malposition Of Device
2
Device Disinfection Or Sterilization Issue
 2
Manufacturing, Packaging Or Shipping Problem
 2
Material Rupture
 1
Component Falling
 1
Entrapment Of Device
 1
Scratched Material
 1
Premature Separation
1
Needle
 1
Noise, Audible
 1
Failure To Discharge
 1
Device Expiration Issue
 1
Labelling, Instructions For Use Or Training Problem
 1
Mushroomed
 1
Incorrect Device Or Component Shipped
 1
Prong
 1
Plug
 1
Contamination Of Device Ingredient Or Reagent
 1
Total Device Problems 1707
Recalls
Manufacturer Recall Class Date Posted
1
Arthrex, Inc.
 II Jan-11-2019
2
Biomet, Inc.
 II May-26-2016
3
ConMed Corporation
 II Dec-14-2017
4
EXP Pharmaceutical Services Corp
 II Jul-24-2015
5
OrthoPediatrics Corp
 II Aug-29-2014
6
Smith & Nephew, Inc. Endoscopy Division
 II Jul-14-2014
7
Stryker Corporation
 II May-10-2016
8
Synthes (USA) Products LLC
 II Jul-07-2016
9
The Anspach Effort, Inc.
 II Jun-25-2014
10
Valeris Medical, LLC
 II Oct-12-2018
11
Valeris Medical, LLC
 II Jul-13-2018
12
Zimmer Biomet, Inc.
 II Sep-26-2018
13
Zimmer Biomet, Inc.
 II May-23-2018
14
Zimmer Biomet, Inc.
 II Mar-15-2018
15
Zimmer Biomet, Inc.
 II Mar-14-2018
16
Zimmer Biomet, Inc.
 II Mar-01-2018
TPLC Last Update: 2019-04-02 20:52:52
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