kneeEOS

Basic Information

• Brand Name: kneeEOS
• Primary DI: 03700757200506
• Version / Model: 1.0
• Company Name: ONEFIT MEDICAL
• Labeler DUNS: 263373588
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 5
• Public Version Date: 2021-02-02
• Public Version Status: Update
• Public Device Record Key: 380c5e6f-ee9b-4156-992e-077c13c3a687
• Distribution End Date: 2020-05-27

Device Description

kneeEOS allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46470	Orthopaedic/craniofacial implantation planning software	A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700757200506	GS1

Customer Contacts

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