ThriveSynth™ Calcium Putty

Primary DI
00816125026807
Brand
ThriveSynth™ Calcium Putty
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
TSCP-10
Catalog number
TSCP-10
Device description
ThriveSynth™ Calcium Putty is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, ThriveSynth™ Calcium Putty resorbs and is later replaced by natural bone. ThriveSynth™ Calcium Putty 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™ Calcium Putty is an osteoconductive putty that is 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 putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone in-growth 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
K022622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022622000CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30PBerkeley Advanced Biomaterials, Inc.2003-01-09MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816125026807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125026807008161250268078161250268070816125026807

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
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
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03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27