Origin Complete Standard Offset Collared Cementless

Primary DI
09348215093136
Brand
Origin Complete Standard Offset Collared Cementless
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-53-0102
Published
2024-12-24
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
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121297000ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.2012-12-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215093136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215093136093482150931369348215093136

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. 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
09348215010973Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Left10-1521-03022026-05-18
09348215010980Active-V Knee Cementless CR Femoral Component - Size 1 Narrow - Right10-1522-03222026-05-18
09348215010997Active-V Knee Cementless CR Femoral Component - Size 1 - Left10-1521-03032026-05-18
09348215011000Active-V Knee Cementless CR Femoral Component - Size 1 - Right10-1522-03232026-05-18
09348215011017Active-V Knee Cementless CRFemoral Component - Size 2 Narrow - Left10-1521-03042026-05-18
09348215011024Active-V Knee Cementless CR Femoral Component - Size 2 Narrow - Right10-1522-03242026-05-18
09348215011031Active-V Knee Cementless CRFemoral Component - Size 2 - Left10-1521-03052026-05-18
09348215011048Active-V Knee Cementless CR Femoral Component - Size 2 - Right10-1522-03252026-05-18
09348215011055Active-V Knee Cementless CRFemoral Component - Size 3 Narrow - Left10-1521-03062026-05-18
09348215011062Active-V Knee Cementless CR Femoral Component - Size 3 Narrow - Right10-1522-03262026-05-18
09348215011079Active-V Knee Cementless CRFemoral Component - Size 3 - Left10-1521-03072026-05-18
09348215011086Active-V Knee Cementless CR Femoral Component - Size 3 - Right10-1522-03272026-05-18
09348215011093Active-V Knee Cementless CRFemoral Component - Size 4 Narrow - Left10-1521-03082026-05-18
09348215011109Active-V Knee Cementless CR Femoral Component - Size 4 Narrow - Right10-1522-03282026-05-18
09348215011116Active-V Knee Cementless CRFemoral Component - Size 4 - Left10-1521-03092026-05-18
09348215011123Active-V Knee Cementless CR Femoral Component - Size 4 - Right10-1522-03292026-05-18
09348215011130Active-V Knee Cementless CRFemoral Component - Size 5 Narrow - Left10-1521-02102026-05-18
09348215011147Active-V Knee Cementless CR Femoral Component - Size 5 Narrow - Right10-1522-02302026-05-18
09348215014506Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 1 Narrow10-1513-04002026-05-18
09348215014513Active-V Knee Cementless Tibial Modular Tray - 40mm Finned Keel - Size 110-1513-04012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996142334POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103489POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103496POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103502POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103519POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103533POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103540POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996152692POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103373POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103380POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103397POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103403POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996098075POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098082POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098099POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098105POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098112POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098129POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098136POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098143POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098150POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098174POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098501POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098518POLARCUPSmith & Nephew, Inc.LPH2015-11-25