Cleared Special

K160025 - iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System

K160025 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 61-day FDA review.

K160025 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
61d
Days
Class 2
Risk

K160025 is an FDA 510(k) clearance for the iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Ret.... 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 March 7, 2016 after a review of 61 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K160025

510(k) Number K160025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2016
Decision Date March 07, 2016
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 K160025.
Optetrak Logic Metaphyseal Cones
K153595 · Exactech, Inc. · Mar 2016
iTotal Cruciate Retaining (CR) Knee Replacement System
K153721 · Conformis, Inc. · Mar 2016
Optetrak Advanced Patella
K160484 · Exactech, Inc. · Mar 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217 · Conformis, Inc. · Jan 2016
Apex Revision Knee System
K153437 · Omnilife Science · Dec 2015
Klassic Knee System
K153310 · Total Joint Orthopedics, Inc. · Dec 2015
K160025 · iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
Download PDF FDA Summary Conformis, Inc.