Cleared Special

K190085 - Journey II Unicompartmental Knee System

K190085 is an FDA 510(k) clearance for Journey II Unicompartmental Knee System, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Special 510(k) pathway after a 25-day FDA review.

K190085 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
25d
Days
Class 2
Risk

K190085 is an FDA 510(k) clearance for the Journey II Unicompartmental Knee System. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on February 11, 2019 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K190085

510(k) Number K190085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2019
Decision Date February 11, 2019
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 114
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K190085.
Bodycad Unicompartmental Knee System
K191150 · Bodycad Laboratories, Inc. · Oct 2019
JOURNEY II Unicompartmental Knee System
K191211 · Smith & Nephew, Inc. · Jul 2019
EMPOWR Partial Knee
K191325 · Encore Medical, L.P. · Jul 2019
MOTO Partial Knee System
K183029 · Medacta International S.A. · Jan 2019
Bodycad Unicompartmental Knee System
K181302 · Bodycad Laboratories, Inc. · Jan 2019
Materialise PKA Guide System
K173970 · Materialise NV · Jul 2018
K190085 · Journey II Unicompartmental Knee System
Download PDF FDA Summary Smith & Nephew, Inc.