Klassic Tibial Baseplate, Revision

Basic Information

• Brand Name: Klassic Tibial Baseplate, Revision
• Primary DI: 00810094701338
• Version / Model: 6201.04.000
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-14
• Public Version: 1
• Public Version Date: 2025-05-22
• Public Version Status: New
• Public Device Record Key: 17a6cc9c-8870-4b53-a696-8093c24d5949

Device Description

Tibial Baseplate Assembly, Revision, Sz 4 This contains the following implant numbers: 6200.04.000 Klassic Tibial Baseplate, Revision, Sz 4 (00810094701277) & 5603.00.000 Klassic Tibial Insert Set Screw for Primary or Revision (00814703012754)

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: MR Conditional
• 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: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32832	Uncoated knee tibia prosthesis, metallic	An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810094701338	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243991	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 4

Storage Conditions

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