FDA.reportPublic FDA data

Bicera® Resorbable Bone Substitute

Primary DI
04719875722295
Brand
Bicera® Resorbable Bone Substitute
Company
WILTROM CO., LTD.
Model
BC-G27(2.0-3.0mm,15c.c.)
Device description
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60%hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Published
2020-12-29
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

Contact Domains#

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
K172237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172237000Bicera Resorbable Bone SubstituteWiltrom Corporation Limited2018-02-02MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719875722295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875722295047198757222954719875722295

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature23 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88636107168yichun@wiltrom.com.tw

Regulatory Flags#

DUNS number
656680902
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873027378Wiltrom Spinal Fixation System40044005 Cross-Link Nut ø=6.0 L=4.52022-11-17
04719873027361Wiltrom Spinal Fixation System43040000 Nut ø=9.5 L=4.62022-11-14
04719873024223WILTROM SPINAL FIXATION SYSTEM43555035 Polyaxial Pedicle Screw ø=5.0 / L=352019-09-10
04719873024216WILTROM SPINAL FIXATION SYSTEM43555030 Polyaxial Pedicle Screw ø=5.0 / L=302019-05-10
04719875729843Wiltrom Spinal Fixation System43587550 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729850Wiltrom Spinal Fixation System43587555 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729867Wiltrom Spinal Fixation System43587560 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729874Wiltrom Spinal Fixation System43587565 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729881Wiltrom Spinal Fixation System43587570 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719873025299Wiltrom Spinal Fixation System43577030 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025305Wiltrom Spinal Fixation System43577035 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025312Wiltrom Spinal Fixation System43577040 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025329Wiltrom Spinal Fixation System43577045 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025336Wiltrom Spinal Fixation System43577050 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025343Wiltrom Spinal Fixation System43577055 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025350Wiltrom Spinal Fixation System43577060 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025367Wiltrom Spinal Fixation System43577065 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025374Wiltrom Spinal Fixation System43577070 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
04719873025381Wiltrom Spinal Fixation System43577530 Polyaxial Reduction Pedicle Screw ø=7.5 L2022-11-30
04719873025398Wiltrom Spinal Fixation System43577535 Polyaxial Reduction Pedicle Screw ø=7.5 L2022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812593023188osteoSPAN GranulesBiogennix, LLCMQV2026-07-24
00812593023195SUMMIT Matrix Granules 10ccBiogennix, LLCMQV2026-07-24
00812593023201SUMMIT Matrix Granules 30ccBiogennix, LLCMQV2026-07-24
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01