Cleared Traditional

K140601 - FLOW-NAIL

K140601 is an FDA 510(k) clearance for FLOW-NAIL, manufactured by Flow-Fx, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K140601 · Flow-Fx, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
114d
Days
Class 2
Risk

K140601 is an FDA 510(k) clearance for the FLOW-NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Flow-Fx, LLC (Washington, US). The FDA issued a Cleared decision on July 2, 2014 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Flow-Fx, LLC devices

FDA 510(k) Submission Details - K140601

510(k) Number K140601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2014
Decision Date July 02, 2014
Days to Decision 114 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 504
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K140601.
EMERGE MEDICAL IM NAIL SYSTEM
K141347 · Emerge Medical · Oct 2014
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
K141103 · Neoortho Produtos Ortopedicos S/A · Sep 2014
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · Advanced Orthopaedic Solutions, Inc. · Jul 2014
PRECICE TRAUMA NAIL SYSTEM
K141447 · Ellipse Technologies, Inc. · Jun 2014
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
K131609 · Xiamen Double Engine Medical Material Co., Ltd. · May 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · Ellipse Technologies, Inc. · May 2014