iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121SPEC

GUDID M572TCR121SPEC021

ITOTAL CR-IPOLY XE-IMPLANT KIT HYBRID-LEFT or right

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: M572TCR121SPEC021
• NIH Device Record Key: 1e4b0a79-8d4c-4877-b779-0e1a709073a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® Cruciate Retaining (CR) Knee Replacement System
• Version Model Number: TCR121SPEC02
• Catalog Number: TCR121SPEC
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com
• Phone: 7813459001
• Email: customer-service@conformis.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572TCR121SPEC021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161366

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-08-15
• Device Publish Date: 2018-08-03

On-Brand Devices [iTotal® Cruciate Retaining (CR) Knee Replacement System]

• M572TCR121SPEC021: ITOTAL CR-IPOLY XE-IMPLANT KIT HYBRID-LEFT or right
• M572TCR1211111011: ITOTAL CR ? IPOLY XE ? IMPLANT KIT UNCAPTURED - LEFT or right