Cleared Traditional

K160537 - Navio

K160537 is an FDA 510(k) clearance for Navio, manufactured by Blue Belt Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

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

FDA 510(k) Submission Details - K160537

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
Combination Product No
PCCP Authorized No
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.

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 381
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K160537.
Stryker OrthoMap Precision Knee system
K162341 · Stryker Leibinger GmbH & Co KG · Oct 2016
TSolution One Cup1 Surgical System
K162195 · THINK Surgical, Inc. · Sep 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · Aesculap Implant Systems, LLC · Jul 2016
Aesculap OrthoPilot Next Generation
K153396 · Aesculap Implant Systems, LLC · May 2016
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016
TSolution One w/ACG+ Surgical System
K153647 · THINK Surgical, Inc. · Feb 2016