FDA.reportPublic FDA data

Klassic Tibial Insert, PS-Post, Std Poly

Primary DI
00814703016097
Brand
Klassic Tibial Insert, PS-Post, Std Poly
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
5304.05.012
Device description
Tibial Insert, PS-Post, Std Poly, Size 5, 12mm
Published
2019-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183596000Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link PolyTotal Joint Orthopedics, Inc.2019-03-29JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814703016097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814703016097008147030160978147030160970814703016097

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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify00The Klassic Knee System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags#

DUNS number
078416717
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692940AP Sizer with Short LegsSRI-100502026-05-15
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05
00810094692742CR Femoral Trial, Grit BlastedSRI-10051.032026-02-05
00810094692759CR Femoral Trial, Grit BlastedSRI-10051.042026-02-05
00810094692766CR Femoral Trial, Grit BlastedSRI-10051.052026-02-05
00810094692773CR Femoral Trial, Grit BlastedSRI-10051.062026-02-05
00810094692780CR Femoral Trial, Grit BlastedSRI-10051.072026-02-05
00810094692506Tibial Broach Impactor, Revision2904.00.0002025-05-14
00810094692278Universal Cone Impactor Head2021.12.0122025-04-24
00810094692285Universal Cone Impactor Head2021.34.0182025-04-24
00810094692292Universal Cone Impactor Head2021.57.0242025-04-24
00810094691950Universal Cone Impactor Head, Size 1, 12°2021.01.0122024-09-06
00810094691967Universa Cone Impactor Head, Size 2, 12°2021.02.0122024-09-06
00810094691974Universal Cone Impactor Head, Size 3, 18°2021.03.0182024-09-06
00810094691981Universal Cone Impactor Head, Size 4, 18°2021.04.0182024-09-06
00810094691998Universal Cone Impactor Head, Size 5, 24°2021.05.0242024-09-06
00810094692001Universal Cone Impactor Head, Size 6, 24°2021.06.0242024-09-06
00810094692018Universal Cone Impactor Head, Size 7, 24°2021.07.0242024-09-06
00819251021197Femoral Stem Impactor with Anteversion 1307.00.0002023-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
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00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29