FDA.reportPublic FDA data

Triathlon

Primary DI
07613327027273
Brand
Triathlon
Company
Howmedica Osteonics Corp.
Model
5537-G-431
Catalog number
5537-G-431
Device description
Total Stabilizer+ Tibial Insert
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327027273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327027273076133270272737613327027273

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706774Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706781Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706798Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706804Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00843575127143MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127150MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127167MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127174MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127181MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127198MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127204MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127211MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127228MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127235MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127242MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127259MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127266MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127273MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127280MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127297MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127303MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127310MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127327MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127334MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127341MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127358MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127365MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127372MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127389MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06