Cleared Special

K173331 - JOURNEY II XR Knee Instruments

K173331 is an FDA 510(k) clearance for JOURNEY II XR Knee Instruments, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 24-day FDA review.

K173331 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
24d
Days
Class 2
Risk

K173331 is an FDA 510(k) clearance for the JOURNEY II XR Knee Instruments. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 24 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 - K173331

510(k) Number K173331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date November 16, 2017
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K173331.
Smith & Nephew Patient Matched Cutting Blocks
K172336 · Smith & Nephew, Inc. · Jan 2018
X-PSI Knee System
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Destiknee™ Total Knee System
K172936 · Meril Healthcare Pvt. , Ltd. · Nov 2017
PROLIXUS TOTAL KNEE SYSTEM
K170534 · Otis Biotech Co., Ltd. · Nov 2017
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
K172326 · Stryker Orthopaedics · Oct 2017
MyKnee PPS-Pin Positioners
K170106 · Medacta International S.A. · Oct 2017
K173331 · JOURNEY II XR Knee Instruments
Download PDF FDA Summary Smith & Nephew, Inc.