Cleared Traditional

K140463 - INTEGRA EXTERNAL FIXATION SYSTEM

K140463 is an FDA 510(k) clearance for INTEGRA EXTERNAL FIXATION SYSTEM, manufactured by Ascension Orthopedic. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K140463 · Ascension Orthopedic · Orthopedic device
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Oct 2014
Decision
228d
Days
Class 2
Risk

K140463 is an FDA 510(k) clearance for the INTEGRA EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Ascension Orthopedic (Providence, US). The FDA issued a Cleared decision on October 10, 2014 after a review of 228 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ascension Orthopedic devices

FDA 510(k) Submission Details - K140463

510(k) Number K140463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date October 10, 2014
Days to Decision 228 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K140463.
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520 · Smith & Nephew, Inc. · Nov 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
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · Zimmer, Inc. · Sep 2014
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
K141078 · Orthofix Srl · Sep 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · Zimmer, Inc. · Jan 2014