Cleared Traditional

K261205 - SPINEART Navigation Instrument System

K261205 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 107-day FDA review.

K261205 · Spineart SA · Orthopedic device
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Jul 2026
Decision
107d
Days
Class 2
Risk

K261205 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 July 29, 2026 after a review of 107 days - within the typical 510(k) review window.

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 - K261205

510(k) Number K261205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2026
Decision Date July 29, 2026
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K261205.
Remex Spine Surgery Navigation - Universal Instruments
K262506 · Remex Medical Corp. · Aug 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
K261410 · Suite 201, National Innovation Centre · Jul 2026
TMINI Miniature Robotic System
K261024 · THINK Surgical, Inc. · Jul 2026
Ion-L Navigated Instruments
K262121 · SurGenTec, LLC · Jul 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · Ecential Robotics · Jul 2026
OTS Hip
K261852 · Ortoma AB · Jul 2026