Cleared Traditional

K153333 - Epic Extremity Cannulated Screw System

K153333 is the FDA 510(k) clearance for Epic Extremity Cannulated Screw System by Epic Extremity, LLC. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K153333 · Epic Extremity, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
61d
Days
Class 2
Risk

K153333 is an FDA 510(k) clearance for the Epic Extremity Cannulated Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Epic Extremity, LLC (Cranberry Twp, US). The FDA issued a Cleared decision on January 19, 2016 after a review of 61 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Epic Extremity, LLC devices

Submission Details

510(k) Number K153333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date January 19, 2016
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 553
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K153333.
The Hammertoe Correction System
K153065 · Life Spine, Inc. · Aug 2016
The Life Spine Subtalar Implant System
K160169 · Life Spine · Jun 2016
Biomet Variable Pitch Compression Screw System
K160058 · Biomet, Inc. · Mar 2016
Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
K152841 · Zimmer, Inc. · Nov 2015
PRO-TOE Hammertoe Fixation System
K151838 · Wrightmedicaltechnologyinc · Sep 2015
ForeFoot STP System
K150871 · Tornier, Inc. · Aug 2015