FDA.reportPublic FDA data

Klassic Knee Tibial Insert, CR/Congruent, Size 2, 12 mm, Final Packed, Sterile

Primary DI
00814703010798
Brand
Klassic Knee Tibial Insert, CR/Congruent, Size 2, 12 mm, Final Packed, Sterile
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
5300.02.012
Published
2015-10-22
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

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112906000KLASSIC KNEE SYSTEMTotal Joint Orthopedics, Inc.2012-02-01JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814703010798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814703010798008147030107988147030107980814703010798

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

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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00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
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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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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