Active-V Knee Cemented Tibial Modular Tray - 40mm Finned Keel - Size 5

Primary DI
09348215157463
Brand
Active-V Knee Cemented Tibial Modular Tray - 40mm Finned Keel - Size 5
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
10-1513-0428
Published
2026-05-18
Public version status
New
Distribution status
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
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253239000Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.2025-12-23MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215157463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215157463093482151574639348215157463

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee tibia prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.

Regulatory Flags#

DUNS number
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215185428Signature Magnum Acetabular Cup111-67-00442026-07-29
09348215185435Signature Magnum Acetabular Cup111-67-00462026-07-29
09348215185442Signature Magnum Acetabular Cup111-67-00482026-07-29
09348215185459Signature Magnum Acetabular Cup111-67-00502026-07-29
09348215185466Signature Magnum Acetabular Cup111-67-00522026-07-29
09348215185473Signature Magnum Acetabular Cup111-67-00542026-07-29
09348215185480Signature Magnum Acetabular Cup111-67-00562026-07-29
09348215185497Signature Magnum Acetabular Cup111-67-00582026-07-29
09348215185503Signature Magnum Acetabular Cup111-67-00602026-07-29
09348215185510Signature Magnum Acetabular Cup111-67-00622026-07-29
09348215185527Signature Magnum Acetabular Cup111-67-00642026-07-29
09348215185534Signature Magnum Acetabular Cup111-67-00662026-07-29
09348215185541Signature Resurfacing Femoral Head111-67-01382026-07-29
09348215185558Signature Resurfacing Femoral Head111-67-01402026-07-29
09348215185565Signature Resurfacing Femoral Head111-67-01422026-07-29
09348215185572Signature Resurfacing Femoral Head111-67-01442026-07-29
09348215185589Signature Resurfacing Femoral Head111-67-01462026-07-29
09348215185596Signature Resurfacing Femoral Head111-67-01482026-07-29
09348215185602Signature Resurfacing Femoral Head111-67-01502026-07-29
09348215185619Signature Resurfacing Femoral Head111-67-01522026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.MBH2020-09-25