Cleared Special

K180334 - LEGION Knee System

K180334 is the FDA 510(k) clearance for LEGION Knee System by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K180334 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
27d
Days
Class 2
Risk

K180334 is an FDA 510(k) clearance for the LEGION Knee System. 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 March 5, 2018 after a review of 27 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K180334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2018
Decision Date March 05, 2018
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 775
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K180334.
Acculoc Total Knee System
K170753 · Rootloc Co., Ltd. · Mar 2018
Klassic® Knee System
K180159 · Total Joint Orthopedics, Inc. · Mar 2018
EMPOWR Universal Tibial Baseplate
K173723 · Encore Medical, L.P. · Mar 2018
Materialise TKA Guide System
K173445 · Materialise NV · Feb 2018
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
K173875 · Stelkast, Inc. · Jan 2018
Unity Total Knee System
K173884 · Corin U.S.A. Limited · Jan 2018