Cleared Traditional

Navio (K160537) - FDA 510(k) Clearance

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

K160537 · Blue Belt Technologies, Inc. · Orthopedic device
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May 2016
Decision
83d
Days
Class 2
Risk

K160537 is an FDA 510(k) clearance for the Navio. 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 May 19, 2016 after a review of 83 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Blue Belt Technologies, Inc. devices

Submission Details

510(k) Number K160537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date May 19, 2016
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 Peers - OLO Orthopedic Stereotaxic Instrument

All 331
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K160537.
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · Smith & Nephew, Inc. · Apr 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · Medtronic Sofamor Danek USA, Inc. · Apr 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · Smith & Nephew, Inc. · Apr 2011
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · Smith & Nephew, Inc. · Feb 2010