FDA.reportPublic FDA data

Klassic Tibial Insert, Ultra-PS, E-Link Poly

Primary DI
00814703014673
Brand
Klassic Tibial Insert, Ultra-PS, E-Link Poly
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
5303.05.014
Device description
Tibial Insert, Ultra-PS, E-Link Poly, size 5, 14mm
Published
2018-03-29
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
K180159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180159000Klassic® Knee SystemTotal Joint Orthopedics, Inc.2018-03-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814703014673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814703014673008147030146738147030146730814703014673

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
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0SRI-10054.002026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1SRI-10054.012026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2SRI-10054.022026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3SRI-10054.032026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4SRI-10054.042026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5SRI-10054.052026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6SRI-10054.062026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7SRI-10054.072026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8SRI-10054.082026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9SRI-10054.092026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10SRI-10054.102026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11SRI-10054.112026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12SRI-10054.122026-07-27
00810094692698Modular Frog Eyes2263.00.0002026-06-09
00810094692704Distal Femoral Cut Block Connector2174.00.0002026-06-09
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mm2264.00.0002026-06-09
00810094692933Magnet Spacer, 5mm2027.00.0002026-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.MBH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29