Filler, Bone Void, Calcium Compound

Device Code: 4627

Product Code(s): MQV

Device Classification Information

Device Type ID4627
Device NameFiller, Bone Void, Calcium Compound
Regulation DescriptionResorbable Calcium Salt Bone Void Filler Device.
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 Number888.3045 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMQV
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4627
DeviceFiller, Bone Void, Calcium Compound
Product CodeMQV
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionResorbable Calcium Salt Bone Void Filler Device.
CFR Regulation Number888.3045 [🔎]
Premarket Reviews
ManufacturerDecision
AGNOVOS HEALTHCARE
 
SUBSTANTIALLY EQUIVALENT
 2
AMEND SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ANIKA THERAPEUTICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ARTOSS GMBH
 
SUBSTANTIALLY EQUIVALENT
 2
BACTERIN INTERNATIONAL INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BAXTER HEALTHCARE CORP.
 
SUBSTANTIALLY EQUIVALENT
 3
BAXTER HEALTHCARE CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
BERKELEY ADVANCED BIOMATERIALS
 
SUBSTANTIALLY EQUIVALENT
 1
BIO2 TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOCOMPOSITES LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOGENNIX, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
BIOSTRUCTURES, LLC
 
SUBSTANTIALLY EQUIVALENT
 3
BIOVENTUS LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CELLUMED CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
COLLAGEN MATRIX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CURASAN AG
 
SUBSTANTIALLY EQUIVALENT
 2
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
HAIDER BIOLOGICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
HANS BIOMED CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
INTEGRA LIFESCIENCE CORPORTATION
 
SUBSTANTIALLY EQUIVALENT
 1
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC SOFAMOR DANEK, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
NANOTHERAPEUTICS, INC
 
SUBSTANTIALLY EQUIVALENT
 1
NOVABONE PRODUCTS, LLC
 
SUBSTANTIALLY EQUIVALENT
 4
NUVASIVE, INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
ORIENTAL RESOURCES DEVELOPMENT LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOGEM LTD
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOREBIRTH CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
ORTHOVITA
 
SUBSTANTIALLY EQUIVALENT
 3
OSTEONOVUS, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
PIONEER
 
SUBSTANTIALLY EQUIVALENT
 1
PIONEER SURGICAL TECHNOLOGY
 
SUBSTANTIALLY EQUIVALENT
 1
PROGENTIX ORTHOBIOLOGY
 
SUBSTANTIALLY EQUIVALENT
 1
PROSIDYAN, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SEASPINE ORTHOPEDICS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
SKELETAL KINETICS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SPINESMITH PARTNERS, LLP
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 3
SYNERGY BIOMEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
SYNERGY BIOMEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SYNERGY BIOMEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
TCM ASSOCIATES LTD
 
SUBSTANTIALLY EQUIVALENT
 1
VIVORTE, INC
 
SUBSTANTIALLY EQUIVALENT
 1
WILTROM CORPORATION LIMITED
 
SUBSTANTIALLY EQUIVALENT
 2
WRIGHT MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 5
XENCO MEDICAL, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
XPAND BIOTECHNOLOGY BV
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 2
Device Problems
Adverse Event Without Identified Device Or Use Problem
 106
Device Operates Differently Than Expected
 24
Use Of Device Problem
 18
No Apparent Adverse Event
 14
Appropriate Term/Code Not Available
 10
Break
 10
Device Inoperable
 9
Migration Or Expulsion Of Device
8
Chemical Problem
 8
Insufficient Information
 7
Difficult To Insert
 6
Shelf Life Exceeded
 5
Improper Or Incorrect Procedure Or Method
 5
Compatibility Problem
 4
Device Expiration Issue
 4
Material Disintegration
 3
Failure To Osseointegrate
 2
Patient-Device Incompatibility
 2
Failure To Eject
2
Metal Shedding Debris
 2
Failure To Deliver
 2
Crack
 2
Packaging Problem
 2
Positioning Problem
 2
Biocompatibility
2
Leak / Splash
 2
Human Factors Issue
 2
Material Too Rigid Or Stiff
 1
Material Separation
 1
Device Packaging Compromised
 1
Inadequacy Of Device Shape And/or Size
 1
Unintended Movement
 1
Device Markings / Labelling Problem
 1
Improper Chemical Reaction
1
Manufacturing, Packaging Or Shipping Problem
 1
Loose Or Intermittent Connection
 1
Malposition Of Device
1
Delivery System Failure
 1
Detachment Of Device Or Device Component
 1
Filling Problem
 1
Collapse
 1
Activation, Positioning Or Separation Problem
 1
Difficult To Open Or Close
 1
Physical Property Issue
 1
Screw
 1
Loss Of Or Failure To Bond
 1
Inadequate Instructions For Healthcare Professional
 1
Label
 1
Difficult Or Delayed Positioning
 1
Device Sensing Problem
 1
Total Device Problems 286
Recalls
Manufacturer Recall Class Date Posted
1
Acumed LLC
 II Aug-23-2017
2
AlloSource, Inc.
 II May-06-2014
3
Apatech Limited
 II Jun-07-2016
4
Howmedica Osteonics Corp.
 II Dec-22-2018
5
Musculoskeletal Transplant Foundation, Inc.
 II Apr-17-2015
6
RTI Surgical, Inc.
 II Mar-10-2017
7
RTI Surgical, Inc.
 II Feb-07-2014
8
Skeletal Kinetics, Llc
 II Jul-24-2015
9
Synthes (USA) Products LLC
 II Jun-09-2016
10
Synthes USA
 II Feb-15-2018
TPLC Last Update: 2019-04-02 20:53:02
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