Cleared Special

K241644 - SPINEART Navigation Instrument System

K241644 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 Special 510(k) pathway after a 61-day FDA review.

K241644 · Spineart SA · Orthopedic device
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Aug 2024
Decision
61d
Days
Class 2
Risk

K241644 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 August 7, 2024 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spineart SA devices

FDA 510(k) Submission Details - K241644

510(k) Number K241644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2024
Decision Date August 07, 2024
Days to Decision 61 days
Submission Type Special
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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 K241644.
Q Guidance System
K241517 · Stryker Leibinger GmbH & Co KG · Aug 2024
TMINI Miniature Robotic System
K242264 · THINK Surgical, Inc. · Aug 2024
360CAS Knee
K242009 · Kico Knee Innovation Company Pty, Ltd. · Aug 2024
Bendini Cloud Application
K233706 · Nuvasive · Aug 2024
Spine Navigation System
K233725 · Medivis, Inc. · Jul 2024
Spine Guidance Software (Version 5.1)
K241171 · Stryker Leibinger GmbH & Co KG · Jul 2024