Cleared Special

K180334 - LEGION Knee System

K180334 is an FDA 510(k) clearance for LEGION Knee System, 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 27-day FDA review.

K180334 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K180334

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.

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 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
K180334 · LEGION Knee System
Download PDF FDA Summary Smith & Nephew, Inc.