Cleared Traditional

K140167 - RENAISSANCE X SYSTEM

K140167 is an FDA 510(k) clearance for RENAISSANCE X SYSTEM, manufactured by Mazor Robotics , Ltd.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K140167 · Mazor Robotics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
230d
Days
Class 2
Risk

K140167 is an FDA 510(k) clearance for the RENAISSANCE X SYSTEM. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Mazor Robotics , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 10, 2014 after a review of 230 days - an extended review 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: 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 Mazor Robotics , Ltd. devices

FDA 510(k) Submission Details - K140167

510(k) Number K140167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2014
Decision Date September 10, 2014
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 371
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K140167.
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Navigated Vertex Select Instruments
K143628 · Medtronic Sofamor Danek USA, Inc. · Feb 2015
UNIVERSAL NAVIGATION INSTRUMENTS
K140927 · Medos International SARL · Oct 2014
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