Cleared Traditional

K171497 - Mikron Spinal Fixation System

K171497 is an FDA 510(k) clearance for Mikron Spinal Fixation System, manufactured by Mikron Makina Sanayi Ticaret Co. , Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K171497 · Mikron Makina Sanayi Ticaret Co. , Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
143d
Days
Class 2
Risk

K171497 is an FDA 510(k) clearance for the Mikron Spinal Fixation System. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Mikron Makina Sanayi Ticaret Co. , Ltd. (Ankara, TR). The FDA issued a Cleared decision on October 12, 2017 after a review of 143 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K171497

510(k) Number K171497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2017
Decision Date October 12, 2017
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K171497.
LumFix Spinal Fixation Sytem
K160731 · CG Bio Co., Ltd. · Oct 2016
Double Medical Universal Spine System
K151458 · Double Medical Technology, Inc. · Aug 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K160124 · Spinevision S.A. · Apr 2016
Premier
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Apr 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016