Cleared Traditional

K140158 - S.E.A.L. FRACTURE FUSION TUBE

K140158 is an FDA 510(k) clearance for S.E.A.L. FRACTURE FUSION TUBE, manufactured by Dne, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K140158 · Dne, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
127d
Days
Class 2
Risk

K140158 is an FDA 510(k) clearance for the S.E.A.L. FRACTURE FUSION TUBE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Dne, LLC (Round Rock, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 127 days - within the typical 510(k) review window.

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 Dne, LLC devices

FDA 510(k) Submission Details - K140158

510(k) Number K140158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date May 29, 2014
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K140158.
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
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · Stryker Trauma AG · Jun 2013
ILIZAROV DRILL TIP WIRES
K130479 · Smith & Nephew, Inc. · May 2013