Cleared Special

K140814 - EVOS MINI-FRAGMENT PLATING SYSTEM

K140814 is an FDA 510(k) clearance for EVOS MINI-FRAGMENT PLATING SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 36-day FDA review.

K140814 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
36d
Days
Class 2
Risk

K140814 is an FDA 510(k) clearance for the EVOS MINI-FRAGMENT PLATING SYSTEM. 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 May 7, 2014 after a review of 36 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.

FDA 510(k) Submission Details - K140814

510(k) Number K140814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date May 07, 2014
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

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 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140814.
MSP METATARSAL SHORTENING SYSTEM
K140724 · Nextremity Solutions, Inc. · May 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · Biomet, Inc. · May 2014
AAP LOQTEC(R) OLECRANON PLATE
K140607 · Aap Implantate AG · May 2014
MATRIXRIB FIXATION SYSTEM
K133616 · Synthes USA Products, LLC · May 2014
ORTHOPEDIC FIXATION SYSTEMS
K140216 · Impact Medical, LLC · May 2014
PINIT SMALL BONE FUSION SYSTEM
K140617 · Arthrosurface, Inc. · Apr 2014
K140814 · EVOS MINI-FRAGMENT PLATING SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.