Cleared Traditional

K140454 - NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS

K140454 is an FDA 510(k) clearance for NAVIGATED CD HORIZON SOLERA SCREWDRIVER..., manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K140454 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2014
Decision
87d
Days
Class 2
Risk

K140454 is an FDA 510(k) clearance for the NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS. 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 Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 87 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 Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K140454

510(k) Number K140454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date May 22, 2014
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K140454.
INTELLIJOINT HIP
K133759 · Intellijoint Surgical, Inc. · Jul 2014
NAVIO
K140596 · Blue Belt Technologies, Inc. · Jul 2014
ORTHALIGN PLUS SYSTEM
K140331 · Orthalign, Inc. · Jun 2014
ORTHOALIGN PLUS SYSTEM
K130387 · Orthalign, Inc. · Nov 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · Medtronic Navigation, Inc. · Aug 2013
S4C NAVIGATION INSTRUMENTS
K130887 · Aesculap Implant System, Inc. · Aug 2013