Cleared Traditional

K153340 - Epic Extremity Plate System

K153340 is an FDA 510(k) clearance for Epic Extremity 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 82-day FDA review.

K153340 · Epic Extremity, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
82d
Days
Class 2
Risk

K153340 is an FDA 510(k) clearance for the Epic Extremity 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 February 9, 2016 after a review of 82 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 - K153340

510(k) Number K153340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date February 09, 2016
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 Consultant

Intrepid Orthopedics, LLC
LEE STRNAD

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 - HRS Plate, Fixation, Bone

All 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K153340.
Biomet Microfixation RibFix Blu Thoracic Fixation System
K152253 · Biomet Microfixation · Mar 2016
Piccolo Composite(R) Distal Volar Radius Plate System
K160002 · CarboFix Orthopedics , Ltd. · Mar 2016
IRENE Locking Compression Plate System
K151508 · Tianjin Zhengtian Medical Instrument Co., Ltd. · Feb 2016
TriMed Humeral Supracondylar Fixation System
K151735 · TriMed, Inc. · Jan 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016
aap LOQTEQ VA Radius Set 2.5
K153034 · Aap Implantate AG · Jan 2016