JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

Primary DI
B278PINS0
Brand
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Company
ONKOS SURGICAL, INC.
Model
ibnpin
Catalog number
PINS
Device description
Bone Pins
Published
2024-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05060296236397PreviousGS10
B278PINS0PrimaryHIBCC0

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 thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080254074
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B278IMPBIMPEXSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/ExSmIMPBIMP-EXSM2024-07-22
B278IMPBIMPSM0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/SmIMPBIMP-SM2024-07-22
B278IMGENIMP0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimgenimpIMGENIMP2024-07-19
B278IMPBIMPSTD0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimpbimp/StdIMPBIMP-STD2024-07-19
B278HDSP03604N0My3D® Personalized Pelvic Reconstruction DG-SP036-04NDG-SP036-04N2023-02-22
B278IMCIRPR0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTimcirprIMCIRPR2024-07-19
B278HC1112003M0ELEOS Limb Salvage System With BioGripHC-11120-03M HC-11120-03M 2021-06-30
B278HC1312003M0ELEOS Limb Salvage System With BioGripHC-13120-03M HC-13120-03M 2021-06-30
B278HC1512003M0ELEOS Limb Salvage System With BioGripHC-15120-03M HC-15120-03M 2021-06-30
B278HC1712003M0ELEOS Limb Salvage System With BioGripHC-17120-03M HC-17120-03M 2021-06-30
B278DV3500004N0My3D® Personalized Pelvic ReconstructionDV-35000-04N2025-09-22
B278DVMOD3504N0My3D® Personalized Pelvic ReconstructionDV-MOD35-04N2025-09-22
B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278LS5001804M0My3D® Personalized Pelvic Reconstruction LS-50018-04M2024-03-11
B278LS5004604M0My3D® Personalized Pelvic Reconstruction LS-50046-04M2024-03-11
B278LS5002004M0My3D® Personalized Pelvic Reconstruction LS-50020-04M2024-03-08
B278LS5002204M0My3D® Personalized Pelvic Reconstruction LS-50022-04M2024-03-08
B278LS5002404M0My3D® Personalized Pelvic Reconstruction LS-50024-04M2024-03-08
B278LS5002504M0My3D® Personalized Pelvic Reconstruction LS-50025-04M2024-03-08
B278LS5002604M0My3D® Personalized Pelvic Reconstruction LS-50026-04M2024-03-08

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