FDA.reportPublic FDA data

World Knee Vit-E UC All Poly Tibia

Primary DI
09348215089993
Brand
World Knee Vit-E UC All Poly Tibia
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
121-20-6469
Published
2023-07-25
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
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220737000World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)Signature Orthopaedics Pty, Ltd.2022-04-11JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215089993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215089993093482150899939348215089993

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, polyethyleneAn 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 entirely of polyethylene (PE) and is not coated with a material 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 is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

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
05056139247712Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDOIY2026-10-19
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05056139247798Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDOIY2026-10-19
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05056139247927Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDOIY2026-10-19
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05056139248023Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248092Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDOIY2026-10-19