Cleared Traditional

iTotal? Identity? Cruciate Retaining (CR) Knee Replacement System (KRS)

K210809 · Conformis, Inc. · Orthopedic

May 2021

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K210809 is an FDA 510(k) clearance for the iTotal? Identity? Cruciate Retaining (CR) Knee Replacement System (KRS), 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 May 12, 2021, 56 days after receiving the submission on March 17, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K210809 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2021
Decision Date	May 12, 2021
Days to Decision	56 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