ITotal® Identity Posterior Stabilized Knee Replacement System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Conformis, Inc.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal® Identity Posterior Stabilized Knee Replacement System.

Pre-market Notification Details

• Device ID: K201023
• 510k Number: K201023
• Device Name: ITotal® Identity Posterior Stabilized Knee Replacement System
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; Conformis, Inc. 600 Technology Park Drive Billerica, MA 01821
• Product Code: JWH
• Subsequent Product Code: OIY
• Subsequent Product Code: OOG
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-20
• Decision Date: 2020-06-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M572RPS0102100131	K201023	000
M572RPS0202100031	K201023	000
M572RPS0202000031	K201023	000
M572RPS0201900031	K201023	000
M572RPS0201800031	K201023	000
M572RPS0201700031	K201023	000
M572RPS0201600031	K201023	000
M572RPS0201500031	K201023	000
M572RPS0201400031	K201023	000
M572RPS0201300031	K201023	000
M572RPS0202200031	K201023	000
M572TPS0100900011	K201023	000
M572TPS3011113011	K201023	000
M572TPS1011112011	K201023	000
M572TPS0100800011	K201023	000
M572TPS0100700011	K201023	000
M572TPS0100600011	K201023	000
M572TPS000D001011	K201023	000
M572TPS0101200011	K201023	000
M572TPS0101100011	K201023	000
M572TPS0101000011	K201023	000
M572RPS0201200031	K201023	000
M572RPS0201100031	K201023	000
M572RPS0201000031	K201023	000
M572RPS0101300031	K201023	000
M572RPS0101200031	K201023	000
M572RPS0101100031	K201023	000
M572RPS0101000031	K201023	000
M572RPS0100900031	K201023	000
M572RPS0100800031	K201023	000
M572RPS0100700031	K201023	000
M572RPS0100600031	K201023	000
M572RPS3011113011	K201023	000
M572RPS0101400031	K201023	000
M572RPS0101500031	K201023	000
M572RPS0200900031	K201023	000
M572RPS0200800031	K201023	000
M572RPS0102200031	K201023	000
M572RPS0102100031	K201023	000
M572RPS0102000031	K201023	000
M572RPS0101900031	K201023	000
M572RPS0101800031	K201023	000
M572RPS0101700031	K201023	000
M572RPS0101600031	K201023	000
M572TPS1011112111	K201023	000
M572RPS0102200131	K201023	000
M572TPS0201200011	K201023	000
M572RPS0101900131	K201023	000
M572RPS0101800131	K201023	000
M572RPS0101700131	K201023	000
M572RPS0101600131	K201023	000
M572RPS0101500131	K201023	000
M572RPS0101400131	K201023	000
M572RPS0101300131	K201023	000
M572RPS0101200131	K201023	000
M572RPS0101100131	K201023	000
M572RPS0102000131	K201023	000
M572TPS0201300011	K201023	000
M572TPS0201100011	K201023	000
M572TPS0201000011	K201023	000
M572TPS0200900011	K201023	000
M572TPS0200800011	K201023	000
M572TPS0200700011	K201023	000
M572TPS0200600011	K201023	000
M572TPS0101400011	K201023	000
M572TPS0101300011	K201023	000
M572TPS0201400011	K201023	000
M572RPS0101000131	K201023	000
M572RPS0100900131	K201023	000
M572RPS0100800131	K201023	000
M572RPS0201300131	K201023	000
M572RPS0201200131	K201023	000
M572RPS0201100131	K201023	000
M572RPS0201000131	K201023	000
M572RPS0200900131	K201023	000
M572RPS0200800131	K201023	000
M572RPS0200700131	K201023	000
M572RPS0200700031	K201023	000
M572RPS0200600131	K201023	000
M572RPS0201400131	K201023	000
M572RPS0201500131	K201023	000
M572RPS0100700131	K201023	000
M572RPS0100600131	K201023	000
M572RPS0202200131	K201023	000
M572RPS0202100131	K201023	000
M572RPS0202000131	K201023	000
M572RPS0201900131	K201023	000
M572RPS0201800131	K201023	000
M572RPS0201700131	K201023	000
M572RPS0201600131	K201023	000
M572RPS0200600031	K201023	000