Cleared Special

iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System

K210252 · Conformis, Inc. · Orthopedic

Feb 2021

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K210252 is an FDA 510(k) clearance for the iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) 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 February 17, 2021, 19 days after receiving the submission on January 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K210252 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2021
Decision Date	February 17, 2021
Days to Decision	19 days
Submission Type	Special
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