iTotal® Identity Cruciate Retaining Knee Replacement System TCR1011112

GUDID M572TCR1011112011

ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMENTED)

Conformis, Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: M572TCR1011112011
• NIH Device Record Key: 70a93732-80bb-41fe-866c-0a5f6944b8d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® Identity Cruciate Retaining Knee Replacement System
• Version Model Number: TCR101111201
• Catalog Number: TCR1011112
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572TCR1011112011 [Primary]

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: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-10-01

On-Brand Devices [iTotal® Identity Cruciate Retaining Knee Replacement System]

• M572TCR020000A011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, A
• M572TCR010100E011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, SINGLE, 10MM
• M572TCR0101000011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, MEDIAL, 10MM
• M572TCR010090D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, SINGLE, 9MM
• M572TCR0100900011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, MEDIAL, 9MM
• M572TCR010080C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, SINGLE, 8MM
• M572TCR0100800011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, MEDIAL, 8MM
• M572TCR010070B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, SINGLE, 7MM
• M572TCR0100700011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, MEDIAL, 7MM
• M572TCR010060A011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, SINGLE, 6MM
• M572TCR0100600011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, MEDIAL, 6MM
• M572TCR010000J011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, J
• M572TCR010000H011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, H
• M572TCR010000G011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, G
• M572TCR010000F011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, F
• M572TCR010000E011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, E
• M572TCR010000D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, D
• M572TCR010000C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, C
• M572TCR010000B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY, LATERAL, B
• M572TCR000SPEC011: ITOTAL IDENTITY CR HYBRID JIGS
• M572TCR000D001011: ITOTAL IDENTITY CR JIGS
• M572STM3011240011: ITOTAL IDENTITY 12X40MM TIBIAL STEM EXTENSION (TITANIUM, CEMENTED)
• M572STM3011220011: ITOTAL IDENTITY 12X20MM TIBIAL STEM EXTENSION (TITANIUM, CEMENTED)
• M572TCR020080C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 8MM
• M572TCR0200800011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 8MM
• M572TCR020070B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 7MM
• M572TCR0200700011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 7MM
• M572TCR020060A011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 6MM
• M572TCR0200600011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 6MM
• M572TCR020000D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, D
• M572TCR020000C011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, C
• M572TCR020000B011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, B
• M572TCR3011113011: ITOTAL IDENTITY CR TIBIAL TRAY (TITANIUM, CEMENTED)
• M572TCR1011112011: ITOTAL IDENTITY CR FEMORAL IMPLANT (COCR, CEMENTED)
• M572TCR020140J011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 14MM
• M572TCR0201400011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 14MM
• M572TCR020130H011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 13MM
• M572TCR0201300011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 13MM
• M572TCR020120G011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 12MM
• M572TCR0201200011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 12MM
• M572TCR020110F011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 11MM
• M572TCR0201100011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 11MM
• M572TCR020100E011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 10MM
• M572TCR0201000011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 10MM
• M572TCR020090D011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, SINGLE, 9MM
• M572TCR0200900011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, MEDIAL, 9MM
• M572TCR020000J011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, J
• M572TCR020000H011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, H
• M572TCR020000G011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, G
• M572TCR020000F011: ITOTAL IDENTITY CR TIBIAL INSERT, IPOLY XE, LATERAL, F