FDA.reportPublic FDA data

SMARTSET

Primary DI
10603295518761
Brand
SMARTSET
Company
DEPUY (IRELAND)
Model
5450-45-500
Catalog number
545045500
Device description
SmartSet V+G Dual Antibiotic Bone Cement 40g
Published
2026-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LODBONE CEMENT
MBBBONE CEMENT, ANTIBIOTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295518761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329551876110603295518761

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene; it does not contain an antimicrobial agent. Disposable devices dedicated to introduction, preparation or delivery may be packaged with the cement. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Keep Out of Sunlight
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHMBB2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHMBB2026-10-28
03760177044326Signature -x CementTEKNIMEDLOD2026-01-23
03760177044326Signature -x CementTEKNIMEDMBB2026-01-23
03760177044333Signature -x CementTEKNIMEDLOD2026-01-23
03760177044333Signature -x CementTEKNIMEDMBB2026-01-23
03760177044340Signature -x CementTEKNIMEDLOD2026-01-23
03760177044340Signature -x CementTEKNIMEDMBB2026-01-23
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040090GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDLOD2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.LOD2025-04-23
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964729033Arthrex Bone Cement HVG21 SRLLOD2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLLOD2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLLOD2024-09-16
08058964728678BRAVO HVG21 SRLLOD2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLMBB2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLLOD2024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLLOD2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLMBB2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLLOD2024-09-16
08058964729002BRAVO MVG21 SRLLOD2024-09-16
08058964729019BRAVO MV+GG21 SRLMBB2024-09-16
08058964729019BRAVO MV+GG21 SRLLOD2024-09-16
08058964729026BRAVO HV+GG21 SRLMBB2024-09-16