Cleared Traditional

ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K162567) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162567 · Blue Ortho · Orthopedic device
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Apr 2017
Decision
203d
Days
Class 2
Risk

K162567 is an FDA 510(k) clearance for the ExactechGPS Total Shoulder Application, Equinoxe Planning Software. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Blue Ortho (La Tronche, FR). The FDA issued a Cleared decision on April 5, 2017 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Blue Ortho devices

Submission Details

510(k) Number K162567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2016
Decision Date April 05, 2017
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
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 345
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K162567.
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · Smith & Nephew, Inc. · May 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · Smith & Nephew, Inc. · Apr 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · Medtronic Sofamor Danek USA, Inc. · Apr 2017
Stryker OrthoMap Versatile Hip System
K162937 · Stryker Corporation · Feb 2017
Navigation Instruments
K153203 · Globus Medical, Inc. · Feb 2016
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015