GMK Revision Total Knee System

Basic Information

• Brand Name: GMK Revision Total Knee System
• Primary DI: 07630030815607
• Version / Model: 02.07.0005
• Company Name: Medacta International SA
• Labeler DUNS: 488227125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-11-18
• Public Version: 4
• Public Version Date: 2020-04-20
• Public Version Status: Update
• Public Device Record Key: 9f3da00f-2bcd-4232-9312-0341790e87b4

Device Description

Offset connector 5mm

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: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
48066	Knee femur stem prosthesis	A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630030815607	GS1

Premarket Submissions

Submission Number	Supplement Number
K102437	000