iUni® iPoly™ Insert Kit

Basic Information

• Brand Name: iUni® iPoly™ Insert Kit
• Primary DI: M572RUK0100700011
• Version / Model: RUK010070001
• Catalog Number: RUK0100700
• 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: 9f55b42b-d8a2-4bb9-936c-f8cfe413fae4
• 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
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3520	2
OOG	Knee Arthroplasty Implantation System	Orthopedic	888.3560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M572RUK0100700011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072586	000

Device Sizes

Type	Value	Unit	Text
Height	7	Millimeter