Cleared Traditional

K172441 - EPIC Extremity Fracture Plate System

K172441 is an FDA 510(k) clearance for EPIC Extremity Fracture Plate System, manufactured by Epic Extremity, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K172441 · Epic Extremity, LLC · Orthopedic device
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Nov 2017
Decision
87d
Days
Class 2
Risk

K172441 is an FDA 510(k) clearance for the EPIC Extremity Fracture Plate System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Epic Extremity, LLC (Cranberry Twp, US). The FDA issued a Cleared decision on November 6, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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

FDA 510(k) Submission Details - K172441

510(k) Number K172441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2017
Decision Date November 06, 2017
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1034
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K172441.
CoLink View Plating System
K172300 · In2bones USA, LLC · Nov 2017
ANTHEM Fracture System
K173166 · Globus Medical, Inc. · Nov 2017
Omni Foot Plating System
K172260 · Extremity Medical, LLC · Nov 2017
ARIX Wrist System
K170705 · Jeil Medical Corporation · Sep 2017
DARCO Locking Bone Plate System
K171852 · Wrightmedicaltechnologyinc · Sep 2017
Footmotion Plating System
K171510 · Newclip Technics · Sep 2017