FDA.reportPublic FDA data

Genflex2 Total Knee System

Primary DI
10840843113164
Brand
Genflex2 Total Knee System
Company
GLOBUS MEDICAL, INC.
Model
SC3754-2.5-10
Device description
GENflex2 CR-HF Tibial Insert, Size 2.5-10
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10840843113164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084084311316410840843113164

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(724)941-6368customer_service@stelkast.com

Regulatory Flags#

DUNS number
139105691
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
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
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

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