Cleared Traditional

K240160 - EGPS Navigated Instruments

K240160 is the FDA 510(k) clearance for EGPS Navigated Instruments by Astura Medical. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K240160 · Astura Medical · Orthopedic device
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Oct 2024
Decision
272d
Days
Class 2
Risk

K240160 is an FDA 510(k) clearance for the EGPS Navigated 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 Astura Medical (Irving, US). The FDA issued a Cleared decision on October 17, 2024 after a review of 272 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 Astura Medical devices

Submission Details

510(k) Number K240160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2024
Decision Date October 17, 2024
Days to Decision 272 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
150d slower than avg
Panel avg: 122d · This submission: 272d
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 354
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K240160.
TMINI Miniature Robotic System
K243285 · THINK Surgical, Inc. · Nov 2024
Mako Shoulder Application (1.0)
K242373 · Mako Surgical Corp. · Nov 2024
ROSA® Knee System
K242864 · Orthosoft Inc. (d/b/a) Zimmer CAS · Oct 2024
CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays
K241893 · Medos International SARL · Sep 2024
Q Guidance System
K241517 · Stryker Leibinger GmbH & Co KG · Aug 2024
TMINI Miniature Robotic System
K242264 · THINK Surgical, Inc. · Aug 2024