Cleared Special

K180271 - NAVIO™ Surgical System (NAVIO system)

K180271 is an FDA 510(k) clearance for NAVIO Surgical System (NAVIO system), manufactured by Blue Belt Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 65-day FDA review.

K180271 · Blue Belt Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
65d
Days
Class 2
Risk

K180271 is an FDA 510(k) clearance for the NAVIO™ Surgical System (NAVIO 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 Blue Belt Technologies, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 6, 2018 after a review of 65 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.

FDA 510(k) Submission Details - K180271

510(k) Number K180271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2018
Decision Date April 06, 2018
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 444
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K180271.
Mazor X
K180307 · Mazor Robotics , Ltd. · Apr 2018
OLYMPIC Navigated Instruments
K172166 · Astura Medical · Apr 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · Smith & Nephew, Inc. · Apr 2018
Navigated Instrument System
K172115 · Orthofix, Inc. · Mar 2018
Navigated INFINITY™ Instruments
K173338 · Medtronic Sofamor Danek USA, Inc. · Jan 2018
K2M Navigation Instruments
K171556 · K2m · Jan 2018
K180271 · NAVIO™ Surgical System (NAVIO system)
Download PDF FDA Summary Blue Belt Technologie…