Cleared Traditional

K131130 - NAVIGATION PIN

K131130 is the FDA 510(k) clearance for NAVIGATION PIN by Evergreen Orthopedic Research Lab. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K131130 · Evergreen Orthopedic Research Lab · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
87d
Days
Class 2
Risk

K131130 is an FDA 510(k) clearance for the NAVIGATION PIN. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Evergreen Orthopedic Research Lab (Kirkland, US). The FDA issued a Cleared decision on July 19, 2013 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Evergreen Orthopedic Research Lab devices

Submission Details

510(k) Number K131130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date July 19, 2013
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.

Device Classification

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 355
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K131130.
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · Medtronic Sofamor Danek USA, Inc. · May 2014
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · Medtronic Navigation, Inc. · Aug 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · Medtronic Navigation, Inc. · Mar 2013
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · Nuvasive, Inc. · Dec 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · Brainlab AG · Nov 2012