Cleared Special

K142404 - iTotal Posterior Stabilized (PS) Knee Replacement System

K142404 is an FDA 510(k) clearance for iTotal Posterior Stabilized (PS) Knee R..., manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 106-day FDA review.

K142404 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
106d
Days
Class 2
Risk

K142404 is an FDA 510(k) clearance for the iTotal Posterior Stabilized (PS) 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. (Bedford, US). The FDA issued a Cleared decision on December 11, 2014 after a review of 106 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142404

510(k) Number K142404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date December 11, 2014
Days to Decision 106 days
Submission Type Special
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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 921
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K142404.
Biomet Tibial trays
K142933 · Biomet, Inc. · Dec 2014
Zimmer Persona Personalized Knee System
K142787 · Zimmer, Inc. · Dec 2014
ANTHEM PS Total Knee System
K142807 · Smith & Nephew, Inc. · Dec 2014
Neo Total Knee System
K142388 · New Era Orthopedics, LLC · Dec 2014
GMK EXTENSION
K142069 · Medacta International · Dec 2014
VEGA Knee System
K143106 · Aesculap Implant Systems, LLC · Nov 2014
K142404 · iTotal Posterior Stabilized (PS) Knee Replacement System
Download PDF FDA Summary Conformis, Inc.