iUni iPoly Implant UKA-111-1111

GUDID M572UKA1111111031

IUNI–IPOLY–IMPLANT KIT–RIGHT or Left LATERAL or medial

Conformis, Inc.

Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis Unicondylar knee prosthesis

• Primary Device ID: M572UKA1111111031
• NIH Device Record Key: fade6be1-4071-41d7-91f3-c0113d1ed03e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iUni iPoly Implant
• Version Model Number: UKA-111-111103
• Catalog Number: UKA-111-1111
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572UKA1111111031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111916

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

Devices Manufactured by Conformis, Inc.

• M572TCR302T07S011 - Identity Imprint Porous CR: 2024-02-01 IDENTITY IMPRINT POROUS CR TIBIAL TRAY SIZE 7
• 00810933031817 - Calcar Planer Adapter Drop-in: 2023-12-13 Calcar Planer Adapter Drop-in ED-09733
• M572POV0123208011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 32MM X 8MM, iPoly
• M572POV0123509011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 35MM X 9MM, iPoly
• M572POV0123809011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 38MM X 9MM, iPoly
• M572POV0124110011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 41MM X 10MM, iPoly
• M572POV0124411011 - Identity Imprint Porous CR: 2023-09-18 POROUS OVAL PATELLA, 44MM X 11MM, iPoly
• M572TCR102F01S011 - Identity Imprint Porous CR: 2023-09-18 POROUS CR FEMORAL IMPLANT SIZE 1 LEFT OR RIGHT