Cleared Special

K152041 - Renaissance X System

K152041 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 Special 510(k) pathway after a 118-day FDA review.

K152041 · Mazor Robotics , Ltd. · Orthopedic device
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Nov 2015
Decision
118d
Days
Class 2
Risk

K152041 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. (Caesarea Park South, IL). The FDA issued a Cleared decision on November 17, 2015 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mazor Robotics , Ltd. devices

FDA 510(k) Submission Details - K152041

510(k) Number K152041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date November 17, 2015
Days to Decision 118 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

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 K152041.
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016
TSolution One w/ACG+ Surgical System
K153647 · THINK Surgical, Inc. · Feb 2016
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Total Knee Application (TKA)
K143752 · Mako Surgical Corp. · Aug 2015
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