FDA.reportPublic FDA data

Conflow G Bone Cement

Primary DI
08031497002101
Brand
Conflow G Bone Cement
Company
TECRES SPA
Model
110043026
Device description
Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow G Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Published
2021-06-09
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
LODBone Cement
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08031497002101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08031497002101080314970021018031497002101

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435428396
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
28031497000101Mendec Spine12302015-10-06
08031497003894InterSpace Hip Trial, 46mm ShortIHT46S2026-02-11
08031497003900InterSpace Hip Trial, 54mm ShortIHT54S2026-02-11
08031497003917InterSpace Hip Trial, 60mm ShortIHT60S2026-02-11
08031497003924InterSpace Hip Trial, 46mm Long IHT46L2026-02-11
08031497003931InterSpace Hip Trial, 54mm LongIHT54L2026-02-11
08031497003948InterSpace Hip Trial, 60mm LongIHT60L2026-02-11
08031497003955Interspace GV Hip Spacer 46IHGV46S2026-02-11
08031497003962Interspace GV Hip Spacer 54IHGV54S2026-02-11
08031497003979Interspace GV Hip Spacer 60IHGV60S2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLIHGV46L2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLIHGV54L2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLIHGV60L2026-02-11
08031497002347InterSpace Knee TrialSPK90Z12022-09-23
08031497002897InterSpace Knee ATS Trial KitSPK90Z22022-09-23
08031497002903InterSpace Knee Trial XLSPK03Z12022-09-23
08031497003689Mendec® Kypho Set Monolateral 10 mmASB030A2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmASB030B2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmASB030C2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmASB032A2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAMBB2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAMBB2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAMBB2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
03760177044326Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044333Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044340Signature -x Cement TEKNIMEDMBB2026-01-23
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964728722Arthrex Bone Cement HV w/GG21 SRLMBB2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLMBB2024-09-16
08058964729019BRAVO MV+GG21 SRLMBB2024-09-16
08058964729026BRAVO HV+GG21 SRLMBB2024-09-16
04260056882623BonOs HV GentaOSARTIS GmbHLOD2024-04-03
03770007907752V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907769V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907776V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907783V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907790V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27