Cleared Special

K180753 - SafetyFix EasyOut System

K180753 is an FDA 510(k) clearance for SafetyFix EasyOut System, manufactured by Safetyfix Medical Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 29-day FDA review.

K180753 · Safetyfix Medical Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
29d
Days
Class 2
Risk

K180753 is an FDA 510(k) clearance for the SafetyFix EasyOut System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Safetyfix Medical Technologies, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 20, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K180753

510(k) Number K180753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date April 20, 2018
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 Global Consulting, LLC
Ken Pilgrim

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K180753.
VariAx 2 System
K180500 · Stryker GmbH · Jun 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932 · Diamond Orthopedic, LLC · May 2018
InCore® Lapidus System
K180257 · Nextremity Solutions, Inc. · Apr 2018
MotoBAND CP Implant System
K173710 · Crossroads Extremity Systems, LLC · Feb 2018
G-Beam Fusion Beaming System
K172698 · Orthofix Srl · Feb 2018
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
K180753 · SafetyFix EasyOut System
Download PDF FDA Summary Safetyfix Medical Tec…