Cleared Traditional

K190562 - iTotal Identity Cruciate Retaining Knee Replacement System

K190562 is an FDA 510(k) clearance for iTotal Identity Cruciate Retaining Knee..., 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 156-day FDA review.

K190562 · Conformis, Inc. · Orthopedic device
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Aug 2019
Decision
156d
Days
Class 2
Risk

K190562 is an FDA 510(k) clearance for the iTotal Identity Cruciate Retaining 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 August 8, 2019 after a review of 156 days - an extended review cycle.

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 - K190562

510(k) Number K190562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date August 08, 2019
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 886
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K190562.
Persona Revision Knee System
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Freedom Primary PCK
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Triathlon Total Knee System-Additional Components
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SurgTech GENOLL Total Knee System
K191192 · Surgtech, Inc. · Aug 2019
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
K183017 · Osteoremedies, LLC · Jul 2019
SPAR-K Instruments (for use with Gemini SL Total Knee System)
K191755 · Waldemar Link GmbH & Co. KG · Jul 2019