Cleared Traditional

FLOW-NAIL (K140601) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140601 · Flow-Fx, LLC · Orthopedic device
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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

Submission Details

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
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.

Device Classification

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 263
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K140601.
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · Synthes (Usa) · Mar 2014
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL
K130595 · Zimmer, Inc. · Sep 2013
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · Smith & Nephew, Inc. · Oct 2012