Cleared Traditional

K173338 - Navigated INFINITY Instruments

K173338 is the FDA 510(k) clearance for Navigated INFINITY Instruments by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K173338 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Jan 2018
Decision
87d
Days
Class 2
Risk

K173338 is an FDA 510(k) clearance for the Navigated INFINITY™ Instruments. 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 January 18, 2018 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

Submission Details

510(k) Number K173338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date January 18, 2018
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.

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 365
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K173338.
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · Smith & Nephew, Inc. · Apr 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · Blue Belt Technologies, Inc. · Apr 2018
Navigated Instrument System
K172115 · Orthofix, Inc. · Mar 2018
K2M Navigation Instruments
K171556 · K2m · Jan 2018
Spineology Navigation Instruments
K172518 · Spineology, Inc. · Jan 2018
NuVasive Navigation Instruments
K172623 · Nu Vasive, Incorporated · Dec 2017