Identity Imprint Knee Replacement System TPS-101-F04S

GUDID M572TPS101F04S011

PS FEMORAL IMPLANT SIZE 4 LEFT or RIGHT

Conformis, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: M572TPS101F04S011
• NIH Device Record Key: 848088dc-0a32-4321-9a4a-3b3c68e2fcf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Identity Imprint Knee Replacement System
• Version Model Number: TPS101F04S01
• Catalog Number: TPS-101-F04S
• 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
• 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

• 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 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	M572TPS101F04S011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210191

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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: 2021-06-09
• Device Publish Date: 2021-06-01

On-Brand Devices [Identity Imprint Knee Replacement System]

• M572TPS301T07S011: PS TIBIAL TRAY SIZE 7
• M572TPS301T06S011: PS TIBIAL TRAY SIZE 6
• M572TPS301T06N011: PS TIBIAL TRAY SIZE 6 NARROW
• M572TPS301T05S011: PS TIBIAL TRAY SIZE 5
• M572TPS301T05N011: PS TIBIAL TRAY SIZE 5 NARROW
• M572TPS301T04S011: PS TIBIAL TRAY SIZE 4
• M572TPS301T04N011: PS TIBIAL TRAY SIZE 4 NARROW
• M572TPS301T03S011: PS TIBIAL TRAY SIZE 3
• M572TPS301T03N011: PS TIBIAL TRAY SIZE 3 NARROW
• M572TPS301T02S011: PS TIBIAL TRAY SIZE 2
• M572TPS301T02N011: PS TIBIAL TRAY SIZE 2 NARROW
• M572TPS301T01S011: PS TIBIAL TRAY SIZE 1
• M572TPS101F07S011: PS FEMORAL IMPLANT SIZE 7 LEFT or RIGHT
• M572TPS101F06S011: PS FEMORAL IMPLANT SIZE 6 LEFT or RIGHT
• M572TPS101F06N011: PS FEMORAL IMPLANT SIZE 6 NARROW LEFT or RIGHT
• M572TPS101F05S011: PS FEMORAL IMPLANT SIZE 5 LEFT or RIGHT
• M572TPS101F05N011: PS FEMORAL IMPLANT SIZE 5 NARROW LEFT or RIGHT
• M572TPS101F04S011: PS FEMORAL IMPLANT SIZE 4 LEFT or RIGHT
• M572TPS101F04N011: PS FEMORAL IMPLANT SIZE 4 Narrow LEFT or RIGHT
• M572TPS101F03S011: PS FEMORAL IMPLANT SIZE 3 LEFT or RIGHT
• M572TPS101F03N011: PS FEMORAL IMPLANT SIZE 3 Narrow LEFT or RIGHT
• M572TPS101F02S011: PS FEMORAL IMPLANT SIZE 2 LEFT or RIGHT
• M572TPS101F02N011: PS FEMORAL IMPLANT SIZE 2 Narrow LEFT or Right
• M572TPS101F01S011: PS FEMORAL IMPLANT SIZE 1 LEFT or Right
• M572TCR301T07S011: CR TIBIAL TRAY SIZE 7
• M572TCR301T06S011: CR TIBIAL TRAY SIZE 6
• M572TCR301T06N01: CR TIBIAL TRAY SIZE 6 NARROW
• M572TCR301T05S011: CR TIBIAL TRAY SIZE 5
• M572TCR301T05N011: CR TIBIAL TRAY SIZE 5 NARROW
• M572TCR301T04S011: CR TIBIAL TRAY SIZE 4
• M572TCR301T04N011: CR TIBIAL TRAY SIZE 4 NARROW
• M572TCR301T03S011: CR TIBIAL TRAY SIZE 3
• M572TCR301T03N011: CR TIBIAL TRAY SIZE 3 NARROW
• M572TCR301T02S011: CR TIBIAL TRAY SIZE 2
• M572TCR301T02N011: CR TIBIAL TRAY SIZE 2 NARROW
• M572TCR301T01S011: CR TIBIAL TRAY SIZE 1
• M572TCR101F07S011: CR FEMORAL IMPLANT SIZE 7 LEFT or Right
• M572TCR101F06S011: CR FEMORAL IMPLANT SIZE 6 LEFT or Right
• M572TCR101F06N011: CR FEMORAL IMPLANT SIZE 6 Narrow LEFT or Right
• M572TCR101F05S011: IDENTITY IMPRINT CR FEMORAL IMPLANT SIZE 5 LEFT or Right
• M572TCR101F05N011: CR FEMORAL IMPLANT SIZE 5 Narrow LEFT or Right
• M572TCR101F04S011: CR FEMORAL IMPLANT SIZE 4 LEFT or RIGHT
• M572TCR101F04N011: CR FEMORAL IMPLANT SIZE 4 Narrow LEFT or Right
• M572TCR101F03S011: CR FEMORAL IMPLANT SIZE 3 LEFT or Right
• M572TCR101F03N011: CR FEMORAL IMPLANT SIZE 3 Narrow LEFT or Right
• M572TCR101F02S011: CR FEMORAL IMPLANT SIZE 2 LEFT or Left
• M572TCR101F02N011: CR FEMORAL IMPLANT SIZE 2 Narrow LEFT or RIGHT
• M572TCR101F01S011: CR FEMORAL IMPLANT SIZE 1 LEFT or RIGHT
• M572TCR020163N011: CR TIBIAL INSERT SIZE 3 NARROW 16MM LEFT AND RIGHT
• M572TCR020162S011: CR TIBIAL INSERT SIZE 2 16MM LEFT AND RIGHT