FDA.reportPublic FDA data

Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right

Primary DI
09348215011024
Brand
Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
10-1522-0324
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
09348215011024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215011024093482150110249348215011024

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee femur prosthesisA sterile implantable device designed to replace the femoral condyles (femoral 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 tibial and, if required, patellar prosthetic components 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
09348215019587Evolve AP Cup - Size 28-40111-17-40282026-06-26
09348215019594Evolve AP Cup - Size 28-42111-17-42282026-06-26
09348215019600Evolve AP Cup - Size 28-44111-17-44282026-06-26
09348215019617Evolve AP Cup - Size 28-46111-17-46282026-06-26
09348215019624Evolve AP Cup - Size 28-48111-17-48282026-06-26
09348215019631Evolve AP Cup - Size 28-50111-17-50282026-06-26
09348215019648Evolve AP Cup - Size 28-52111-17-52282026-06-26
09348215019655Evolve AP Cup - Size 28-54111-17-54282026-06-26
09348215019662Evolve AP Cup - Size 28-56111-17-56282026-06-26
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mm121-20-41202026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mm121-20-42202026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mm121-20-43202026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mm121-20-44202026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mm121-20-45202026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mm121-20-46202026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mm121-20-47202026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mm121-20-48202026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mm121-20-49202026-06-26
09348215148980Evolve AP Vit-E Cup – Neutral - Size 32-46111-17-01462026-06-26
09348215148997Evolve AP Vit-E Cup – Neutral - Size 32-48111-17-01482026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215046019World Knee Cemented Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046026World Knee Cemented Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046033World Knee Cemented Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046040World Knee Cemented Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046057World Knee Cemented Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046064World Knee Cemented Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046071World Knee Cemented Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046088World Knee Cemented Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215046095World Knee Cemented Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161088World Knee CR TiN Cementless Femur - Size 2 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161095World Knee CR TiN Cementless Femur - Size 3 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161101World Knee CR TiN Cementless Femur - Size 4 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161118World Knee CR TiN Cementless Femur - Size 5 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161125World Knee CR TiN Cementless Femur - Size 6 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161132World Knee CR TiN Cementless Femur - Size 7 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161149World Knee CR TiN Cementless Femur - Size 8 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161156World Knee CR TiN Cementless Femur - Size 9 RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161163World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161170World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161187World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161194World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161200World Knee Cementless Titanium Tibial Plate - Modular - Size 5 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161217World Knee Cementless Titanium Tibial Plate - Modular - Size 6 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161224World Knee Cementless Titanium Tibial Plate - Modular - Size 7 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161231World Knee Cementless Titanium Tibial Plate - Modular - Size 8 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161248World Knee Cementless Titanium Tibial Plate - Modular - Size 9 - 40mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161255World Knee Cementless Titanium Tibial Plate - Modular - Size 1 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161262World Knee Cementless Titanium Tibial Plate - Modular - Size 2 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161279World Knee Cementless Titanium Tibial Plate - Modular - Size 3 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26
09348215161286World Knee Cementless Titanium Tibial Plate - Modular - Size 4 - 80mmSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-26