Klassic Tibial Insert Set Screw, for Primary or Revision

GUDID 00814703012754

TOTAL JOINT ORTHOPEDICS, INC.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 00814703012754
• NIH Device Record Key: d6cde3ec-cd61-47b7-a399-cfde816ae34c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert Set Screw, for Primary or Revision
• Version Model Number: 5603.00.000
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)486-6070
• Email: udi@tjoinc.com
• Phone: +1(801)486-6070
• Email: udi@tjoinc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703012754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112906

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814703012754]

Radiation Sterilization

[00814703012754]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

• 00810094701000 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 1-2, 5mm
• 00810094701017 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 1-2, 10mm
• 00810094701024 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 3-4, 5mm
• 00810094701031 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 3-4, 10mm
• 00810094701048 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 5-6, 5mm
• 00810094701055 - Klassic Tibial Augment: 2024-12-16 Tibial Augment, Size 5-6, 10mm
• 00810094701062 - Klassic Tibial Augment & Screw: 2024-12-16 Includes: Tibial Augment, Size 1-2, 5mm (00810094701000) and Augment Screw, 5mm (00814703019968)
• 00810094701079 - Klassic Tibial Augment & Screw: 2024-12-16 Includes: Tibial Augment, Size 1-2, 10mm (00810094701017) and Augment Screw, 10mm (00814703019975)