Cleared Special

K190253 - EVOS Small Fragment Upper Extremity Pla...

K190253 is the FDA 510(k) clearance for EVOS Small Fragment Upper Extremity Pla... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 32-day FDA review.

K190253 · Smith & Nephew, Inc. · Orthopedic device
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Mar 2019
Decision
32d
Days
Class 2
Risk

K190253 is an FDA 510(k) clearance for the EVOS Small Fragment Upper Extremity Plates Line Additions. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 11, 2019 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K190253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2019
Decision Date March 11, 2019
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K190253.
ATLAS Plating System
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MIS Bunion Plating System
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Stryker SternalPlate System
K183172 · Stryker · Mar 2019
MLP Special Locking Bone Plate System
K181843 · Maxxion Medical, LLC / Baumer SA · Mar 2019
MIS Bunion System
K181872 · Crossroads Extremity Systems, LLC · Feb 2019