Cleared Special

K142520 - Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software

K142520 is an FDA 510(k) clearance for Smith & Nephew, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 73-day FDA review.

K142520 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
73d
Days
Class 2
Risk

K142520 is an FDA 510(k) clearance for the Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on November 20, 2014 after a review of 73 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

FDA 510(k) Submission Details - K142520

510(k) Number K142520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2014
Decision Date November 20, 2014
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 358
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K142520.
Orthofix True Lok Hexapod System VI.3
K143125 · Orthofix Srl · Dec 2014
ORTHOFIX GALAXY WRIST
K141760 · Orthofix Srl · Dec 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052 · Orthofix Srl · Dec 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K140961 · Stryker Trauma AG · Nov 2014
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
K141912 · Advanced Orthopaedic Solutions, Inc. · Oct 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463 · Ascension Orthopedic · Oct 2014