FDA.reportPublic FDA data

Active-V Knee Cemented Tibial Modular Tray - 40mm Finned Keel - Size 2 Narrow

Primary DI
09348215157401
Brand
Active-V Knee Cemented Tibial Modular Tray - 40mm Finned Keel - Size 2 Narrow
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
10-1513-0422
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
09348215157401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215157401093482151574019348215157401

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
09348215199890Triple Taper Stem Standard Offset Collared Size 069-00112026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 069-00122026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 069-00212026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 069-00222026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 169-01112026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 169-01122026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 169-01212026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 169-01222026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 269-02112026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 269-02122026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 269-02212026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 269-02222026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 369-03112026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 369-03122026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 369-03212026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 369-03222026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 469-04112026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 469-04122026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 469-04212026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 469-04222026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20