FDA.reportPublic FDA data

Stanmore

Primary DI
05060296232016
Brand
Stanmore
Company
Stanmore Implants Worldwide Ltd
Model
Smbsh02
Catalog number
SMBSH02
Device description
Bushes STD
Published
2019-07-18
Public version status
Update
Distribution status
Not 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
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092138000
K133152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092138000JTS EXTENDEABLE IMPLANTStanmore Implants Worldwide , Ltd.2011-03-22KRO
K133152000JTS EXTENDIBLE DISTAL FEMORAL IMPLANTStanmore Implants Worldwide , Ltd.2014-01-22KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060296232016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060296232016050602962320165060296232016

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
494989502
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060296233839InstrumentimgenimpIMGENIMP2019-07-18
05060296233853Instrumentimpbimp/StdIMPBIMP-STD2019-07-18
05060296233877Instrumentimpbimp/SmIMPBIMP-SM2019-07-18
05060296236182Instrumentimpbimp/ExSmIMPBIMP-EXSM2019-07-18
05060296233693InstrumentimcirprIMCIRPR2019-07-18
05060296236397InstrumentibnpinPINS2019-07-18
05060296233709InstrumentimtrfhIMTRFH2019-07-18
05060296233761Instrumentimtrrhm/StdIMTRRHM-STD2019-07-18
05060296233778Instrumentimtrrhm/SmIMTRRHM-SM2019-07-18
05060296233846Instrumentimtrrhp/SmIMTRRHP-SM2019-07-18
05060296233860Instrumentimtrrhp/StdIMTRRHP-STD2019-07-18
05060296236151Instrumentimtrrhm/ExSmIMTRRHM-EXSM2019-07-18
05060296236175Instrumentimtrrhp/ExSmIMTRRHP-EXSM2019-07-18
05060296236304Instrumentimtrp/ExSmIMTRP-EXSM2019-07-18
05060296236311Instrumentimtrp/SmIMTRP-SM2019-07-18
05060296236328Instrumentimtrp/StdIMTRP-STD2019-07-18
05060296230272Stanmoremktp/Sm5MKTP-SM52019-07-18
05060296230289Stanmoremktp/Sm10MKTP-SM102019-07-18
05060296230296Stanmoremktp/Sm15MKTP-SM152019-07-18
05060296230302Stanmoremktp/Sm20MKTP-SM202019-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295529712ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529729ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529736ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529743ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529750ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529767ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529774ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529781ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529798ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529804ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529811ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529828ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529835ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529842ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529859ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529866ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529873ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529880ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529897ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529927ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529934ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529941ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529958ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295530008ATTUNEDEPUY (IRELAND)KRO2025-10-31