iTotal Identity Posterior Stabilized Knee Replacement System RPS-010-1200

GUDID M572RPS0101200031

ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY, 12MM

Conformis, Inc.

Tibial insert

• Primary Device ID: M572RPS0101200031
• NIH Device Record Key: be581b2d-f0b6-4a5c-ac92-595ac68d1a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal Identity Posterior Stabilized Knee Replacement System
• Version Model Number: RPS010120003
• Catalog Number: RPS-010-1200
• 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: 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: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RPS0101200031 [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: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [iTotal Identity Posterior Stabilized Knee Replacement System]

• M572TPS0201200011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 12MM, RIGHT
• M572TPS0201100011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 11MM, RIGHT
• M572TPS0201000011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 10MM
• M572TPS0200900011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 9MM
• M572TPS0200800011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 8MM
• M572TPS0200700011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 7MM
• M572TPS0200600011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 6MM
• M572TPS0101300011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 13MM
• M572TPS0201400011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 14MM
• M572TPS0201300011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY XE, 13MM
• M572RPS0102000131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 20MM
• M572RPS0101900131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 19MM
• M572RPS0101800131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 18MM
• M572RPS0101700131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 17MM
• M572RPS0101600131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 16MM
• M572RPS0101500131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 15MM
• M572RPS0101400131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 14MM
• M572RPS0101300131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 13MM
• M572RPS0101200131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 12MM
• M572RPS0101100131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 11MM
• M572RPS0101000131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 10MM
• M572RPS0100900131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 9MM
• M572RPS0100800131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 8MM
• M572RPS0100700131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 7MM
• M572RPS0100600131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 6MM
• M572RPS0202200131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 22MM
• M572RPS0202100131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 21MM
• M572RPS0202000131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 20MM
• M572RPS0201900131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 19MM
• M572RPS0201800131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 18MM
• M572RPS0201700131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 17MM
• M572RPS0201600131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 16MM
• M572RPS0201500131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 15MM
• M572RPS0201400131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 14MM
• M572RPS0201300131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 13MM
• M572RPS0201200131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 12MM
• M572RPS0201100131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 11MM
• M572RPS0201000131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 10MM
• M572RPS0200900131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 9MM
• M572RPS0200800131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 8MM
• M572RPS0200700131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 7MM
• M572RPS0200700031: ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY XE, 7MM, RIGHT
• M572RPS0200600131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY XE, 6MM
• M572RPS0200600031: ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY XE, 6MM, RIGHT
• M572RPS0102200131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 22MM
• M572RPS0102100131: ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 21MM
• M572TPS3011113011: ITOTAL IDENTITY PS TIBIAL TRAY, (TITANIUM, CEMENTED)
• M572TPS1011112011: ITOTAL IDENTITY PS FEMORAL IMPLANT (COCR, CEMENTED)
• M572TPS0100800011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 8MM
• M572TPS0100700011: ITOTAL IDENTITY PS TIBIAL INSERT, IPOLY, 7MM