Klassic Femoral Augment Screw, Distal

Basic Information

• Brand Name: Klassic Femoral Augment Screw, Distal
• Primary DI: 00814703019999
• Version / Model: 6407.00.010
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• Labeler DUNS: 078416717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-03
• Public Version: 2
• Public Version Date: 2025-06-09
• Public Version Status: Update
• Public Device Record Key: 0b119158-b774-48cc-a8d0-e5f2f5be12d2

Device Description

Femoral Augment Screw, Distal, 10mm

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: 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
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	888.3565	2
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63998	Implantable orthopaedic/craniofacial device connection screw	A small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814703019999	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230537	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10mm

Storage Conditions

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