Cleared Traditional

K170280 - Smith & Nephew SURESHOT Distal Targetin...

K170280 is the FDA 510(k) clearance for Smith & Nephew SURESHOT Distal Targetin... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K170280 · Smith & Nephew, Inc. · Orthopedic device
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Apr 2017
Decision
88d
Days
Class 2
Risk

K170280 is an FDA 510(k) clearance for the Smith & Nephew SURESHOT Distal Targeting System V4.0. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 88 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K170280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2017
Decision Date April 28, 2017
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 364
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K170280.
Mako Total Knee Application
K170581 · Mako Surgical Corp. · May 2017
Mako Partial Knee Application
K170584 · Mako Surgical Corp. · May 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · Smith & Nephew, Inc. · May 2017
Mako Total Hip Application
K170593 · Mako Surgical Corp. · Apr 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · Medtronic Sofamor Danek USA, Inc. · Apr 2017
Navigated Instrument System
K162921 · Orthofix, Inc. · Mar 2017