Cleared Traditional

K163226 - EPIC Extremely Small Staple

K163226 is an FDA 510(k) clearance for EPIC Extremely Small Staple, manufactured by Epic Extremely, LLC. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K163226 · Epic Extremely, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
180d
Days
Class 2
Risk

K163226 is an FDA 510(k) clearance for the EPIC Extremely Small Staple. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Epic Extremely, LLC (Cranberry Twp, US). The FDA issued a Cleared decision on May 16, 2017 after a review of 180 days - an extended review 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: 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.

View all Epic Extremely, LLC devices

FDA 510(k) Submission Details - K163226

510(k) Number K163226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2016
Decision Date May 16, 2017
Days to Decision 180 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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 141
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K163226.
Orbitum Bone Staple Implant, X and VI
K173693 · Orthovestments, LLC · Feb 2018
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
Arthrex DynaNite Nitinol Staple
K172052 · Arthrex, Inc. · Dec 2017
NeoSpan Compression Staple Impant w/instruments
K161426 · In2bones USA, LLC · Oct 2016
EasyStep
K160813 · Stryker GmbH · Jul 2016
OS2(R)-VP Varisation Staple
K153770 · In2bones Sas · Mar 2016