Cleared Traditional

K131425 - NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER

K131425 is an FDA 510(k) clearance for NAVIGATED CAPSTONE TRIALS, manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K131425 · Medtronic Navigation, Inc. · Orthopedic device
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Aug 2013
Decision
89d
Days
Class 2
Risk

K131425 is an FDA 510(k) clearance for the NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER. 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 Navigation, Inc. (Memphis, US). The FDA issued a Cleared decision on August 14, 2013 after a review of 89 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 Navigation, Inc. devices

FDA 510(k) Submission Details - K131425

510(k) Number K131425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date August 14, 2013
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K131425.
ORTHALIGN PLUS SYSTEM
K140331 · Orthalign, Inc. · Jun 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · Medtronic Sofamor Danek USA, Inc. · May 2014
ORTHOALIGN PLUS SYSTEM
K130387 · Orthalign, Inc. · Nov 2013
S4C NAVIGATION INSTRUMENTS
K130887 · Aesculap Implant System, Inc. · Aug 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · Smith & Nephew, Inc. · Aug 2013
NAVIGATION PIN
K131130 · Evergreen Orthopedic Research Lab · Jul 2013