Cleared Special

K190085 - Journey II Unicompartmental Knee System

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

K190085 · Smith & Nephew, Inc. · Orthopedic device
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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.

View all Smith & Nephew, Inc. devices

Submission Details

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.

Device Classification

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 98
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K190085.
Bodycad Unicompartmental Knee System
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JOURNEY II Unicompartmental Knee System
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K183029 · Medacta International S.A. · Jan 2019
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K181302 · Bodycad Laboratories, Inc. · Jan 2019
Materialise PKA Guide System
K173970 · Materialise NV · Jul 2018