ATTUNE

Basic Information

• Brand Name: ATTUNE
• Primary DI: 10603295416296
• Version / Model: 1506-11-007
• Catalog Number: 150611007
• Company Name: DEPUY (IRELAND)
• Labeler DUNS: 989365556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 7
• Public Version Date: 2021-08-10
• Public Version Status: Update
• Public Device Record Key: c58d3e2a-6930-4974-9d4b-689fb7c1a7ab

Device Description

Attune Knee System TIBIAL BASE POROCOAT ROTATING PLATFORM SIZE 7 CEMENTLESS

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
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
34198	Coated knee tibia prosthesis	A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10603295416296	GS1

Customer Contacts

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