Cleared Traditional

K160713 - Stealth-Midas System

K160713 is an FDA 510(k) clearance for Stealth-Midas System, manufactured by Medtronic Powered Surgical Solutions. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K160713 · Medtronic Powered Surgical Solutions · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
72d
Days
Class 2
Risk

K160713 is an FDA 510(k) clearance for the Stealth-Midas 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 Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on May 26, 2016 after a review of 72 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 Medtronic Powered Surgical Solutions devices

FDA 510(k) Submission Details - K160713

510(k) Number K160713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2016
Decision Date May 26, 2016
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 Consultant

Medtronic Navigation
JOHN CONNOR

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 440
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K160713.
Precision Screw
K160385 · Cryptych Pty, Ltd. · Jul 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · Aesculap Implant Systems, LLC · Jul 2016
Styrker OrthoMap Express Knee System
K153240 · Stryker Corporate · Jul 2016
Navio
K160537 · Blue Belt Technologies, Inc. · May 2016
Aesculap OrthoPilot Next Generation
K153396 · Aesculap Implant Systems, LLC · May 2016
Alphatec Navigation Instruments
K153603 · Alphatec Spine, Inc. · Apr 2016