Cleared Traditional

iTotal Identity Cruciate Retaining Knee Replacement System

K190562 · Conformis, Inc. · Orthopedic

Aug 2019

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K190562 is an FDA 510(k) clearance for the iTotal Identity Cruciate Retaining Knee Replacement System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on August 8, 2019, 156 days after receiving the submission on March 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K190562 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2019
Decision Date	August 08, 2019
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560