JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

Primary DI
B278IMOSTME150
Brand
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Company
ONKOS SURGICAL, INC.
Model
imostme/15
Catalog number
IMOSTME-15
Device description
Osteotome
Published
2024-07-19
Public version status
New
Distribution status
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
05060296233754PreviousGS10
B278IMOSTME150PrimaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060296233754050602962337545060296233754

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable 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
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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
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B278DVRDG3504N0My3D® Personalized Pelvic ReconstructionDV-RGD35-04N2025-09-22
B278PINS0JTS EXTENDIBLE DISTAL FEMORAL IMPLANTibnpinPINS2024-07-22
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

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