Cleared Traditional

K210191 - Identity Imprint Knee Replacement System

K210191 is an FDA 510(k) clearance for Identity Imprint Knee Replacement System, manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K210191 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
101d
Days
Class 2
Risk

K210191 is an FDA 510(k) clearance for the Identity Imprint Knee Replacement System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on May 6, 2021 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Conformis, Inc. devices

FDA 510(k) Submission Details - K210191

510(k) Number K210191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 897
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K210191.
LinkSymphoKnee System
K202924 · Waldemar Link GmbH & Co. KG · May 2021
GMK Spherika Femurs and Fixed Tibial Trays Plus
K211004 · Medacta International S.A. · May 2021
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
K210809 · Conformis, Inc. · May 2021
Genius / Genuin Total Knee System
K200765 · Biorad Medisys Pvt, Ltd. · May 2021
MOBIO Total Knee System
K210483 · B-One Ortho, Corp. · Apr 2021
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K210961 · United Orthopedic Corporation · Apr 2021