Duracon

Basic Information

• Brand Name: Duracon
• Primary DI: 07613327033045
• Version / Model: 6630-6-255
• Catalog Number: 6630-6-255
• Company Name: Howmedica Osteonics Corp.
• Labeler DUNS: 058311945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-19
• Public Version: 5
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 0ed59d11-5e7d-4ffa-be2b-c9a372a4f8ec

Device Description

Flat Tibial Wedge

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: No
• 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	07613327033045	GS1

Premarket Submissions

Submission Number	Supplement Number
K223069	000
K915512	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: MED-2
Device Size Text, specify			Thickness: 10.0 Millimeter