PURpillars™ Advanced Collagen Matrix Strip

Primary DI
00816125024292
Brand
PURpillars™ Advanced Collagen Matrix Strip
Company
BERKELEY ADVANCED BIOMATERIALS, LLC
Model
PURpillars-100x10x5
Catalog number
PURpillars-100x10x5
Device description
PURpillars™ Advanced Collagen Matrix Strip is a sterile bone graft composed of purified fibrillar Type I collagen and 60% hydroxyapatite (HAP) – 40% tricalcium phosphate (TCP) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone. PURpillars™ Advanced Collagen Matrix Strip is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine 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 by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices.
Published
2023-01-23
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
K092046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092046000BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTYBerkeley Advanced Biomaterials, Inc.2010-03-24MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816125024292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816125024292008161250242928161250242920816125024292

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, compositeA sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
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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
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07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
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03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
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03760191134843AktiBone GranulesNORAKERMQV2026-05-27
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