Total Identity Posterior Stabilized Knee Replacement System TPS0101400

GUDID M572TPS0101400011

ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 14MM

Conformis, Inc.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: M572TPS0101400011
• NIH Device Record Key: 807b20f7-2c6a-4690-82c0-ee0452ccc814
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Identity Posterior Stabilized Knee Replacement System
• Version Model Number: TPS010140001
• Catalog Number: TPS0101400
• 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: 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: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com
• Phone: 781-345-0001
• Email: customer-service@conformis.com

Device Dimensions

• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572TPS0101400011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201023

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: 2020-07-09
• Device Publish Date: 2020-07-01

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