Tibial Insert Trial, PS-Max, Klassic ONE

Basic Information

• Brand Name: Tibial Insert Trial, PS-Max, Klassic ONE
• Primary DI: 00819251028684
• Version / Model: 2252.02.012
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-02
• Public Version: 2
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: cf2e4f63-3ffa-45af-ba26-c0da514a8412

Device Description

Tibial Insert Trial, PS-Max, Klassic ONE Size 2, 12mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58716	Knee tibia prosthesis trial, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819251028684	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 2, 12mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The Klassic Knee System should be stored in a clean, dry location at room temperature