Cleared Traditional

K202836 - GX Navigation Instrument System

K202836 is the FDA 510(k) clearance for GX Navigation Instrument System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code OLO) cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K202836 · Life Spine, Inc. · Orthopedic device
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Aug 2021
Decision
328d
Days
Class 2
Risk

K202836 is an FDA 510(k) clearance for the GX Navigation Instrument System. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on August 19, 2021 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Life Spine, Inc. devices

Submission Details

510(k) Number K202836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2020
Decision Date August 19, 2021
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
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 K202836.
Dark Star Navigation Instrument System
K212028 · Republic Spine, LLC · Sep 2021
Virage Navigation System
K212023 · Zimmer Biomet Spine, Inc. · Aug 2021
ExcelsiusHub
K211616 · Globus Medical, Inc. · Aug 2021
VERTICALE Navigation Instruments
K212007 · Silony Medical GmbH · Aug 2021
NuVasive Pulse System
K210574 · Nu Vasive, Incorporated · Jul 2021
ARVIS Surgical Navigation System
K203115 · Insight Medical Systems, Inc. · Jul 2021