iTotal® Identity Cruciate Retaining Knee Replacement System

Basic Information

• Brand Name: iTotal® Identity Cruciate Retaining Knee Replacement System
• Primary DI: M572TCR3011113011
• Version / Model: TCR301111301
• Catalog Number: TCR3011113
• Company Name: Conformis, Inc.
• Labeler DUNS: 808821883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 2
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 8313fd5e-ea3c-450a-aff6-8a5cc7d29e9a

Device Description

ITOTAL IDENTITY CR TIBIAL TRAY (TITANIUM, CEMENTED)

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
OOG	Knee Arthroplasty Implantation System	Orthopedic	888.3560	2
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32832	Uncoated knee tibia prosthesis, metallic	An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M572TCR3011113011	HIBCC

Customer Contacts

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