AccessGUDID - DEVICE: iDuo® Tibial Kit (M572RBK1011113021)

GUDID

Device Identifier (DI) Information

Brand Name: iDuo® Tibial Kit
Version or Model: RBK101111302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RBK1011113
Company Name: Conformis, Inc.

Primary DI Number: M572RBK1011113021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808821883 *Terms of Use

Device Description: IDUO–TIBIAL TRAY KIT–LEFT or right MEDIAL or lateral

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
58228	Bicompartmental knee prosthesis	A sterile implantable device designed to replace the patellofemoral and medial tibiofemoral articulating surfaces of a damaged/degenerative (e.g., arthritic) knee during primary or revision bicompartmental replacement of the joint; it is intended to permit retention of the lateral tibiofemoral compartment and both cruciate ligaments. The device is made of metal [e.g., oxidized zirconium alloy, cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OOG	Knee Arthroplasty Implantation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093513	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
Device Size Text, specify: Patient Specific

Device Record Status

Public Device Record Key: 92d707d2-1c49-4297-8630-d9150bef055a
Public Version Date: August 15, 2022
Public Version Number: 4
DI Record Publish Date: October 26, 2015