iDuo® Bicompartmental Knee Replacement System

Basic Information

• Brand Name: iDuo® Bicompartmental Knee Replacement System
• Primary DI: M572BKA1111111011
• Version / Model: BKA111111101
• Catalog Number: BKA1111111
• Company Name: Conformis, Inc.
• Labeler DUNS: 808821883
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-26
• Public Version: 4
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: 76c63675-c244-43ca-b39b-c1fdff0c9348
• Distribution End Date: 2022-08-15

Device Description

N/A

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: Labeling does not contain MRI Safety Information
• 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
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	888.3560	2
OOG	Knee Arthroplasty Implantation System	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M572BKA1111111011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093513	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Patient Specific