Synthetic Backfill Bioimplant Ø6.5 x 40mm

Primary DI
00816125024704
Brand
Synthetic Backfill Bioimplant Ø6.5 x 40mm
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
MSBG6540
Catalog number
MSBG6540
Device description
The Synthetic Backfill Bioimplant is designed as a bone void filler, incorporating a collagen matrix enriched with hydroxyapatite (HA) and tri-calcium phosphate (TCP) granules, along with 45S5 bioactive glass granules. This implant utilizes biocompatible bovine fibrillar collagen and bioactive 45S5 glass particles. The granular composition includes 60 wt% HA and 40 wt% TCP, with the graft containing 20 wt% of 45S5 granules. This device serves as a scaffold to facilitate new bone growth. A sequence of surface reactions on the granules leads to the creation of a calcium phosphate layer that closely mimics the composition and structure of bone mineral hydroxyapatite. This layer, along with the HA-TCP granules, forms an osteoconductive scaffold that supports the growth of the patient’s new bone. As healing progresses, the graft material is gradually absorbed and transformed into new bone.
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00816125024704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125024704008161250247048161250247040816125024704

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it 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. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081067703
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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00816125026654ThriveSynth™ Collagen Foam StripTSCFS1-50X25-02TSCFS1-50X25-022026-05-19
00816125026661ThriveSynth™ Collagen Foam StripTSCFS2-50X10-02TSCFS2-50X10-022026-05-19
00816125026678ThriveSynth™ Collagen Foam StripTSCFS1-100X25-05TSCFS1-100X25-052026-05-19

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