FDA.reportPublic FDA data

Instrument

Primary DI
05060296236397
Brand
Instrument
Company
Stanmore Implants Worldwide Ltd
Model
ibnpin
Catalog number
PINS
Device description
Bone Pins
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

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
05060296236397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060296236397050602962363975060296236397

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
494989502
Device count
1
Lot or batch
true
Sterilization required before use
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
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
05060296230319Stanmoremktp/Std5MKTP-STD52019-07-18

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