Cleared Traditional

K143222 - FIREFLY Pedicle Screw Navigation Guide

K143222 is an FDA 510(k) clearance for FIREFLY Pedicle Screw Navigation Guide, manufactured by Mighty Oak Medical, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K143222 · Mighty Oak Medical, Inc. · Orthopedic device
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Dec 2015
Decision
396d
Days
Class 2
Risk

K143222 is an FDA 510(k) clearance for the FIREFLY Pedicle Screw Navigation Guide. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Mighty Oak Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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. Elevated predicate reliance profile. 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 Mighty Oak Medical, Inc. devices

FDA 510(k) Submission Details - K143222

510(k) Number K143222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date December 11, 2015
Days to Decision 396 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
274d slower than avg
Panel avg: 122d · This submission: 396d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 290
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K143222.
Premier
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Apr 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
YAHUA Spinal System
K152324 · Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. · Feb 2016
WASTON General Spinal System
K150684 · Changzhou Waston Medical Appliance Co., Ltd. · Nov 2015
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Gemmed pedicle screw spinal system
K151592 · Suzhou Gemmed Medical Instrument Co., Ltd. · Sep 2015