FDA.reportPublic FDA data

Origin TT High Offset Size 4

Primary DI
09348215137618
Brand
Origin TT High Offset Size 4
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
59-0104
Published
2025-03-20
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
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2
OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243029000Origin™ TT StemSignature Orthopaedics Pty, Ltd.2025-03-11LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215137618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215137618093482151376189348215137618

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without 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
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.MEH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LPH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.KWZ2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.KWZ2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.LZO2016-10-20