FDA.reportPublic FDA data

MOBIO™ Total Knee System

Primary DI
00843575105653
Brand
MOBIO™ Total Knee System
Company
B-ONE ORTHO, CORP.
Model
8821343019
Catalog number
8821343019
Device description
PS+ Tibial Insert, Size A/3-4+, 19mm thickness, Vitamin E UHMWPE
Published
2019-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843575105653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843575105653008435751056538435751056530843575105653

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-stabilized total knee prosthesisA sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative joint [total knee arthroplasty (TKA)] or for prosthesis revision; it is implanted when the posterior cruciate ligament is sacrificed and uses a “cam and post†mechanism to replace the stabilizing function of the ligament. It includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE); it may be implanted with or without bone cement and is often used in cases where bone stock and mediolateral stability are good in the face of severe deformities or ligament degeneration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081315444
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843575127143MOBIO™ Total Knee System882133110988213311092026-03-06
00843575127150MOBIO™ Total Knee System882133111088213311102026-03-06
00843575127167MOBIO™ Total Knee System882133111188213311112026-03-06
00843575127174MOBIO™ Total Knee System882133111388213311132026-03-06
00843575127181MOBIO™ Total Knee System882133111688213311162026-03-06
00843575127198MOBIO™ Total Knee System882133111988213311192026-03-06
00843575127204MOBIO™ Total Knee System882133112288213311222026-03-06
00843575127211MOBIO™ Total Knee System882133112588213311252026-03-06
00843575127228MOBIO™ Total Knee System882133130988213313092026-03-06
00843575127235MOBIO™ Total Knee System882133131088213313102026-03-06
00843575127242MOBIO™ Total Knee System882133131188213313112026-03-06
00843575127259MOBIO™ Total Knee System882133131388213313132026-03-06
00843575127266MOBIO™ Total Knee System882133131688213313162026-03-06
00843575127273MOBIO™ Total Knee System882133131988213313192026-03-06
00843575127280MOBIO™ Total Knee System882133132288213313222026-03-06
00843575127297MOBIO™ Total Knee System882133132588213313252026-03-06
00843575127303MOBIO™ Total Knee System882133150988213315092026-03-06
00843575127310MOBIO™ Total Knee System882133151088213315102026-03-06
00843575127327MOBIO™ Total Knee System882133151188213315112026-03-06
00843575127334MOBIO™ Total Knee System882133151388213315132026-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024704695Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-27
00889024704619Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-08
00889024704749Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-08
00889024704862Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2026-01-08
00889024704541Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704565Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704589Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704657Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704664Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704718Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704763Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704824Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024704848Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOIY2025-12-23
00889024658134Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658165Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658189Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658226Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658264Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658295Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658301Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658363Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658400Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658417Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658455Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658493Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658516Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658523Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658561Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658622Persona® Knee SystemZimmer, Inc.OIY2025-02-06
00889024658653Persona® Knee SystemZimmer, Inc.OIY2025-02-06