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510(k) Data Aggregation
K Number
K071199Device Name
BONALIVE GRANULES
Manufacturer
VIVOXID LTD.
Date Cleared
2008-02-01
(277 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
VIVOXID LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonAlive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BonAlive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. The device is not intended for use in posterolateral spine applications.
BonAlive® granules is not indicated for use in load-bearing applications, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
Device Description
BonAlive® granules is a sterile medical device made of S53P4 bioactive glass. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue.
The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%. BonAlive® granules functions in contact with body fluids allowing a progressive healing process which develops from the periphery to the central part of the obliteration mass. Best results are obtained by ensuring close contact of the device with surrounding tissue and by carefully following the instructions for clinical use.
When used in the extremities and pelvis, BonAlive® granules is intended to be used alone. BonAlive® granules is sterilized in hot dry air and available in different granule and unit sizes.
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K Number
K071937Device Name
BONALIVE GRANULES AND BONALIVE PLATES
Manufacturer
VIVOXID LTD.
Date Cleared
2007-10-19
(98 days)
Product Code
KKY
Regulation Number
878.3500Why did this record match?
Applicant Name (Manufacturer) :
VIVOXID LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonAlive™ Granules and BonAlive™ Plate are intended for the augmentation or reconstruction of the cranio-maxillofacial skeleton.
Device Description
BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to guide tissue growth, bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive and bacterialgrowth inhibiting material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P>O5 4%. BonAlive™ products are supplied as granules and plates. Both are bone grafting materials intended to fill, augment, or reconstruct bony defects of the cranial and maxillofacial region. BonAlive™ granules and plates are sterilized in hot dry air. The granules are available as different granule and unit sizes. The plates are available in different shapes and sizes.
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K Number
K070055Device Name
BONALIVE GRANULES AND BONALIVE PLATES
Manufacturer
VIVOXID LTD.
Date Cleared
2007-06-25
(172 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
VIVOXID LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BonAlive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws.
Device Description
BonAlive™ products are sterile medical devices made of S53P4 bioactive glass. Bioactive glasses are characterised by their ability to attach firmly to living tissue. Other properties include being able to bond chemically with surrounding bone in an implantation bed and promote new bone formation in the implanted area. Bone bonding is a physico-chemical process leading to continuity between an implant and bone matrix. It has been shown that tissue bonds to bioactive glass due to formation of a silica-gel layer on the glass. The silica-rich layer acts as a template for a calcium phosphate precipitation, which then bonds the bioactive glass to the surrounding bone. This makes the bioactive glass a unique material for filling defects and replacing damaged bony tissue. The composition of this synthetic, osteoconductive material is, by weight, SiO2 53%, Na2O 23%, CaO 20% and P2O5 4%.
BonAlive™ products are supplied as granules are bone grafting materials intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. BonAlive™ granules are sterilized in hot dry air. The granules are available as different granule and unit sizes.
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