iTotal® iPoly XE™ Patella PAT0213808

GUDID M572PAT0213808011

N/A

Conformis, Inc.

Polyethylene patella prosthesis

• Primary Device ID: M572PAT0213808011
• NIH Device Record Key: 116f33a7-3b9d-43a4-b7d6-cbe910415a3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® iPoly XE™ Patella
• Version Model Number: PAT021380801
• Catalog Number: PAT0213808
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Dimensions

• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter
• Outer Diameter: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572PAT0213808011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142161

FDA Product Code

• OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-26

On-Brand Devices [iTotal® iPoly XE™ Patella]

• M572PAT0214110011: N/A
• M572PAT0213808011: N/A
• M572PAT0213507011: N/A
• M572PAT0213206011: N/A
• M572PAT0212906011: N/A