FDA.report

Tibial Insert Trial, PS-Post

Primary DI
00819251025324
Brand
Tibial Insert Trial, PS-Post
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
2224.01.010
Device description
Tibial Insert Trial, PS-Post, Size 1, 10mm
Published
2019-11-25
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

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819251025324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819251025324008192510253248192510253240819251025324

GMDN Terms

TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

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

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags

DUNS number
078416717
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00810094692674Klassic Knee Template, Tibial Baseplate, Revision2909.00.0002026-01-07
00810094692476Narrow Distal Femur Cut BlockSRI-100472025-08-27
00810094692544Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2417.00.2002025-07-28
00810094692339Acetabular Reamer AdapterSRI-100442025-06-26
00810094691790Klassic Knee Templates, Stem Extensions2806.00.0002025-05-14
00810094692322Spline Wrench, Closed2017.00.1002025-05-14
00810094692346Intramedullary Reamer, Revision2026.10.0002025-05-14
00810094692353Intramedullary Reamer, Revision2026.11.0002025-05-14
00810094692360Intramedullary Reamer, Revision2026.12.0002025-05-14
00810094692377Intramedullary Reamer, Revision2026.13.0002025-05-14
00810094692384Intramedullary Reamer, Revision2026.14.0002025-05-14
00810094692391Intramedullary Reamer, Revision2026.15.0002025-05-14
00810094692407Intramedullary Reamer, Revision2026.16.0002025-05-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26