VitaFuse™ Bioactive Glass Graft

Primary DI
00816125027132
Brand
VitaFuse™ Bioactive Glass Graft
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
03-00022
Catalog number
03-00022
Device description
VitaFuse™ Bioactive Glass Graft is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive. VitaFuse™ Bioactive Glass Graft is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. VitaFuse™ Bioactive Glass Graft must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
Published
2026-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170917000Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials2017-10-30MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816125027132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125027132008161250271328161250271320816125027132

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Regulatory Flags#

DUNS number
081067703
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816125027125VitaFuse™ Bioactive Glass Graft03-0002103-000212026-07-06
00816125027149VitaFuse™ Bioactive Glass Graft03-0002303-000232026-07-06
00816125023660OsteoBoost Select 5ccOB-05DOB-05D2020-06-12
00816125023677OsteoBoost Select 10ccOB-10DOB-10D2020-06-12
00816125023707Tribio® DP Cotton WedgeC10 SWC05C10 SWC052020-11-13
00816125023714Tribio® DP Cotton WedgeC10 SWC06C10 SWC062020-11-13
00816125023721Tribio® DP Cotton WedgeC10 SWC07C10 SWC072020-11-13
00816125023738Tribio® DP Cotton WedgeC10 SWC08C10 SWC082020-11-13
00816125023745Tribio® DP Evans WedgeC10 SWE06C10 SWE062020-11-13
00816125023752Tribio® DP Evans WedgeC10 SWE08C10 SWE082020-11-13
00816125023769Tribio® DP Evans WedgeC10 SWE10C10 SWE102020-11-13
00816125023776Tribio® DP Evans WedgeC10 SWE12C10 SWE122020-11-13
00816125023813Bi-Ostetic Foam PuttyBF-01PBF-01P2020-10-05
00816125023820Bi-Ostetic Foam PuttyBF-02PBF-02P2020-10-05
00816125023837Bi-Ostetic Foam PuttyBF-05PBF-05P2020-10-05
00816125023844Bi-Ostetic Foam PuttyBF-10PBF-10P2020-10-05
00816125023851HA-TCP SpongeARM-TCP-10ARM-TCP-102020-11-11
00816125023868HA-TCP-Bioglass SpongeARM-TCP-BA-12ARM-TCP-BA-122020-11-11
00816125023929PURcrystals™ BioCeramic NanoCrystalsPURcrystals-10PURcrystals-102022-12-19
00816125023943PURcrystals™ BioCeramic NanoCrystalsPURcrystals-15PURcrystals-152022-12-19

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