Cleared Special

Mazor X (K180307) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180307 · Mazor Robotics , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
87d
Days
Class 2
Risk

K180307 is an FDA 510(k) clearance for the Mazor X. 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 April 30, 2018 after a review of 87 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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

Submission Details

510(k) Number K180307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2018
Decision Date April 30, 2018
Days to Decision 87 days
Submission Type Special
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 K180307.
ADAPT for Gamma3
K173946 · Stryker GmbH · May 2018
7D Surgical System
K180352 · 7D Surgical, Inc. · May 2018
Spineology Navigation Instruments
K180796 · Spineology, Inc. · May 2018
OLYMPIC Navigated Instruments
K172166 · Astura Medical · Apr 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · Smith & Nephew, Inc. · Apr 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · Blue Belt Technologies, Inc. · Apr 2018