Cleared Traditional

K230846 - iTotal Identity Knee Replacement System

Also marketed or referenced as:
Identity Imprint Knee Replacement System

K230846 is an FDA 510(k) clearance for iTotal Identity 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 111-day FDA review.

K230846 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
111d
Days
Class 2
Risk

K230846 is an FDA 510(k) clearance for the iTotal Identity 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 July 17, 2023 after a review of 111 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 - K230846

510(k) Number K230846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date July 17, 2023
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 884
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K230846.
Balanced Knee® System TriMax PS Plus Tibial Insert
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K231037 · Medacta International S.A. · Jun 2023
Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
K230952 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jun 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
K231233 · Conformis, Inc. · May 2023