Cleared Traditional

iTotal? Identity Posterior Stabilized Knee Replacement System

K201023 · Conformis, Inc. · Orthopedic

Jun 2020

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K201023 is an FDA 510(k) clearance for the iTotal? Identity Posterior Stabilized 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 June 16, 2020, 57 days after receiving the submission on April 20, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K201023 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2020
Decision Date	June 16, 2020
Days to Decision	57 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