AccessGUDID - DEVICE: iTotal® CR iPoly® XE Insert Kit (M572RCR0201500131)

GUDID

Device Identifier (DI) Information

Brand Name: iTotal® CR iPoly® XE Insert Kit
Version or Model: RCR020150013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RCR0201500
Company Name: Conformis, Inc.

Primary DI Number: M572RCR0201500131
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: ITOTAL CR IPOLY XE 15MM MEDIAL INSERT KIT LEFT or right NO TRIAL

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OOG	Knee Arthroplasty Implantation System
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153721	000
K161366	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 15 Millimeter

Device Record Status

Public Device Record Key: 75425a67-69c2-4ae0-a4fe-88cb5de1c73d
Public Version Date: August 15, 2022
Public Version Number: 3
DI Record Publish Date: April 27, 2018