Cleared Traditional

K242933 - SPINEART Navigation Instrument System

K242933 is an FDA 510(k) clearance for SPINEART Navigation Instrument System, manufactured by Spineart SA. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K242933 · Spineart SA · Orthopedic device
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Jun 2025
Decision
266d
Days
Class 2
Risk

K242933 is an FDA 510(k) clearance for the SPINEART 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 Spineart SA (Plan Les Ouates, CH). The FDA issued a Cleared decision on June 18, 2025 after a review of 266 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 Spineart SA devices

FDA 510(k) Submission Details - K242933

510(k) Number K242933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2024
Decision Date June 18, 2025
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLO Device Classification - Class 2, Special Controls

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 370
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K242933.
CORUS™ Navigation System-GX
K251060 · Providence Medical Technology, Inc. · Jul 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
K251073 · Innovasis, Inc. · Jul 2025
TMINI Miniature Robotic System
K250877 · THINK Surgical, Inc. · Jun 2025
Stealth™ Spine Clamps
K242464 · Medtronic Navigation, Inc. · Jun 2025
Paradigm System
K250879 · Proprio, Inc. · Jun 2025
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
K251315 · Remex Medical Corp. · May 2025