Cleared Traditional

K141401 - EASY OUT

K141401 is an FDA 510(k) clearance for EASY OUT, manufactured by Feet For Life Podiatry Center. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K141401 · Feet For Life Podiatry Center · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
268d
Days
Class 2
Risk

K141401 is an FDA 510(k) clearance for the EASY OUT. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Feet For Life Podiatry Center (St. Louis, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 268 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.

FDA 510(k) Submission Details - K141401

510(k) Number K141401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date February 20, 2015
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
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 Consultant

Emergo Group
Carrie Hetrick

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1056
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K141401.
Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw
K143165 · Zimmer, Inc. · Mar 2015
Flow-Screw
K142776 · Flow-Fx, LLC · Mar 2015
Extremity Medical Calcaneal Osteotomy Device
K150309 · Extremity Medical, LLC · Mar 2015
Nexis osteosynthesis snap-off screws
K143146 · Novastep · Feb 2015
Nexis osteosynthesis compressive screws
K143229 · Novastep · Feb 2015
Extremity Medical Calcaneal Osteotomy Device
K143402 · Extremity Medical, LLC · Feb 2015
K141401 · EASY OUT
Download PDF FDA Summary Feet For Life Podiatr…