GENESIS II

Basic Information

• Brand Name: GENESIS II
• Primary DI: 03596010209160
• Version / Model: 71420734
• Catalog Number: 71420734
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 7
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 3c3031e7-249b-411a-adf5-1e9fff910ecc

Device Description

GENESIS II STEPPED HEMI TIBIAL WEDGE SIZE 5-6 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: 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	03596010209160	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951987	000