FDA.reportPublic FDA data

MOBIO™ Total Knee System

Primary DI
00843575105141
Brand
MOBIO™ Total Knee System
Company
B-ONE ORTHO, CORP.
Model
8821200600
Catalog number
8821200600
Device description
Tibial Baseplate, Keeled, Non-Stemmable, Size F, Cemented; Ti Alloy
Published
2019-05-13
Public version status
Update
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
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
00843575105141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575105141008435751051418435751051410843575105141

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] 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/or 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
081315444
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843575106445MOBIO™ Total Knee System882133320988213332092026-05-29
00843575106452MOBIO™ Total Knee System882133321088213332102026-05-29
00843575106469MOBIO™ Total Knee System882133321188213332112026-05-29
00843575106476MOBIO™ Total Knee System882133321388213332132026-05-29
00843575106483MOBIO™ Total Knee System882133321688213332162026-05-29
00843575106490MOBIO™ Total Knee System882133321988213332192026-05-29
00843575106506MOBIO™ Total Knee System882133322288213332222026-05-29
00843575106513MOBIO™ Total Knee System882133322588213332252026-05-29
00843575106520MOBIO™ Total Knee System882134320988213432092026-05-29
00843575106537MOBIO™ Total Knee System882134321088213432102026-05-29
00843575106544MOBIO™ Total Knee System882134321188213432112026-05-29
00843575106551MOBIO™ Total Knee System882134321388213432132026-05-29
00843575106568MOBIO™ Total Knee System882134321688213432162026-05-29
00843575106575MOBIO™ Total Knee System882134321988213432192026-05-29
00843575106582MOBIO™ Total Knee System882134322288213432222026-05-29
00843575106599MOBIO™ Total Knee System882134322588213432252026-05-29
00843575107619MOBIO™ Total Knee System882930200988293020092026-05-29
00843575107626MOBIO™ Total Knee System882930201088293020102026-05-29
00843575107633MOBIO™ Total Knee System882930201188293020112026-05-29
00843575107640MOBIO™ Total Knee System882930201388293020132026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29