Cleared Traditional

Mazor X System (Mazor X Stealth Edition) (K182077) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182077 · Mazor Robotics , Ltd. · Orthopedic device
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Nov 2018
Decision
93d
Days
Class 2
Risk

K182077 is an FDA 510(k) clearance for the Mazor X System (Mazor X Stealth Edition). 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, IL). The FDA issued a Cleared decision on November 2, 2018 after a review of 93 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. 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

Submission Details

510(k) Number K182077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2018
Decision Date November 02, 2018
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 Consultant

A. Stein – Regulatory Affairs Consulting , Ltd.
Ahava Stein

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K182077.
Choice Spine Navigation System
K182721 · Choicespine, LP · Jan 2019
BridalVeil Navigated Instruments
K182982 · Astura Medical · Jan 2019
Brainlab Compatible K2M Navigation Instruments
K181890 · K2m · Nov 2018
NavLock Trackers, Robotic Reference Frame
K182104 · Medtronic Navigation · Nov 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · Medtronic Sofamor Danek USA, Inc. · Nov 2018
Spine Wave Navigated Instruments
K181596 · Spine Wave, Inc. · Oct 2018