Cleared Traditional

K142776 - Flow-Screw

K142776 is an FDA 510(k) clearance for Flow-Screw, manufactured by Flow-Fx, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K142776 · Flow-Fx, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
178d
Days
Class 2
Risk

K142776 is an FDA 510(k) clearance for the Flow-Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Flow-Fx, LLC (Mokena, US). The FDA issued a Cleared decision on March 23, 2015 after a review of 178 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K142776

510(k) Number K142776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2014
Decision Date March 23, 2015
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 711
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K142776.
PHALINX Hammertoe System
K150252 · Wrightmedicaltechnologyinc · Apr 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
K150974 · Aap Implantate AG · Apr 2015
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165 · Zimmer, Inc. · Mar 2015
Extremity Medical Calcaneal Osteotomy Device
K150309 · Extremity Medical, LLC · Mar 2015
Extremity Medical Calcaneal Osteotomy Device
K143402 · Extremity Medical, LLC · Feb 2015
Cannulated Screw System
K143460 · Wrightmedicaltechnologyinc · Jan 2015