iTotal® CR iPoly® XE Insert Kit

Basic Information

• Brand Name: iTotal® CR iPoly® XE Insert Kit
• Primary DI: M572RCR020000F131
• Version / Model: RCR020000F13
• Catalog Number: RCR020000F
• Company Name: Conformis, Inc.
• Labeler DUNS: 808821883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-27
• Public Version: 3
• Public Version Date: 2022-08-15
• Public Version Status: Update
• Public Device Record Key: a26f325f-9220-45f8-92e5-913c987c7666

Device Description

ITOTAL CR IPOLY XE LATERAL F INSERT KIT LEFT or right NO TRIAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
46585	Tibial insert	An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M572RCR020000F131	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153721	000
K161366	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Patient Specific