Home GUDID 07613327207163 INSTRUMENT
Primary DI 07613327207163
Brand INSTRUMENT
Company Howmedica Osteonics Corp.
Model 5510-T-101
Catalog number 5510-T-101
Device description TRIATHLON TOTAL KNEE SYSTEM FEMORAL TRIAL COMPONENT
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HRY PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER KRR PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER NPJ PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2 HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic 2 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613327207163 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613327207163 07613327207163 7613327207163
GMDN Terms# Term, Definition table Term Definition Knee femur prosthesis trial, reusable A copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Device Size Text, specify 0
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 058311945 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097536705 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536781 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536798 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536804 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536804 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536811 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536811 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 E31442411410 Signature Materialise NV HRY 2026-09-24 E31442411410 Signature Materialise NV MBH 2026-09-24 E31442411410 Signature Materialise NV JWH 2026-09-24 E31442422415 Signature Materialise NV MBH 2026-09-24 E31442422415 Signature Materialise NV JWH 2026-09-24 E31442422450 Signature Materialise NV MBH 2026-09-24 E31442422450 Signature Materialise NV JWH 2026-09-24 E31442422451 Signature Materialise NV JWH 2026-09-24 E31442422451 Signature Materialise NV MBH 2026-09-24 E31442422452 Signature Materialise NV JWH 2026-09-24