Cleared Traditional

Identity Imprint Knee Replacement System

K210191 · Conformis, Inc. · Orthopedic

May 2021

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K210191 is an FDA 510(k) clearance for the Identity Imprint 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 May 6, 2021, 101 days after receiving the submission on January 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K210191 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2021
Decision Date	May 06, 2021
Days to Decision	101 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