3DMetal Diaphyseal Femoral Cones

Basic Information

• Brand Name: 3DMetal Diaphyseal Femoral Cones
• Primary DI: 07630971259225
• Version / Model: 02.07.FCM25
• Company Name: Medacta International SA
• Labeler DUNS: 488227125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 2
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 466578c2-5b40-40ce-acc7-410182f0225f

Device Description

3DMetal Diaphyseal Femoral Cone Size Medium

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
48067	Knee arthroplasty wedge	An implantable device designed to augment the implantation of a knee femur or tibia prosthesis by serving as a space-filler adjacent to the prosthesis, typically to replace lost bone and increase bone contact area and aid stability. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630971259225	GS1

Premarket Submissions

Submission Number	Supplement Number
K200075	000