ThriveSynth™ HA/TCP Granules

Primary DI
00816125026708
Brand
ThriveSynth™ HA/TCP Granules
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
TSHG-01G
Catalog number
TSHG-01G
Device description
ThriveSynth™ HA/TCP Granules is a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. ThriveSynth™ HA/TCP Granules is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. ThriveSynth™ HA/TCP Granules is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.ThriveSynth™ HA/TCP Granules is an osteoconductive bone substitute shaped as granules or blocks that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The ThriveSynth™ HA/TCP Granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. ThriveSynth™ HA/TCP Granules is biocompatible and resorbs in the body as bone ingrowth occurs.
Published
2026-05-19
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
K023703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023703000BI-OSTETICBerkeley Advanced Biomaterials, Inc.2003-01-30MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816125026708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125026708008161250267088161250267080816125026708

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.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816125027125VitaFuse™ Bioactive Glass Graft03-0002103-000212026-07-06
00816125027132VitaFuse™ Bioactive Glass Graft03-0002203-000222026-07-06
00816125027149VitaFuse™ Bioactive Glass Graft03-0002303-000232026-07-06
00816125026487ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-01TSBGP-012026-05-19
00816125026494ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-05TSBGP-052026-05-19
00816125026500ThriveSynth™ Bioactive Glass Foam PuttyTSBGP-10TSBGP-102026-05-19
00816125026517ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X10-01TSBGS1-50X10-012026-05-19
00816125026524ThriveSynth™ Bioactive Glass Foam StripTSBGS2-50X10-02TSBGS2-50X10-022026-05-19
00816125026531ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X10-02TSBGS1-50X10-022026-05-19
00816125026548ThriveSynth™ Bioactive Glass Foam StripTSBGS2-50X10-05TSBGS2-50X10-052026-05-19
00816125026555ThriveSynth™ Bioactive Glass Foam StripTSBGS1-50X25-06TSBGS1-50X25-062026-05-19
00816125026562ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-10TSBGS1-100X25-102026-05-19
00816125026579ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-12TSBGS1-100X25-122026-05-19
00816125026586ThriveSynth™ Bioactive Glass Foam StripTSBGS1-100X25-15TSBGS1-100X25-152026-05-19
00816125026593ThriveSynth™ Collagen Foam PuttyTSCFP-01TSCFP-012026-05-19
00816125026609ThriveSynth™ Collagen Foam PuttyTSCFP-02TSCFP-022026-05-19
00816125026616ThriveSynth™ Collagen Foam PuttyTSCFP-05TSCFP-052026-05-19
00816125026623ThriveSynth™ Collagen Foam PuttyTSCFP-10TSCFP-102026-05-19
00816125026630ThriveSynth™ Collagen Foam StripTSCFS1-50X10-01TSCFS1-50X10-012026-05-19
00816125026647ThriveSynth™ Collagen Foam StripTSCFS1-50X10-02TSCFS1-50X10-022026-05-19

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