Cleared Traditional

K261113 - Op.n™ Spine Navigation and Robotic Guidance

K261113 is an FDA 510(k) clearance for Op.n Spine Navigation and Robotic Guidance, manufactured by Ecential Robotics. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K261113 · Ecential Robotics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
110d
Days
Class 2
Risk

K261113 is an FDA 510(k) clearance for the Op.n™ Spine Navigation and Robotic Guidance. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Ecential Robotics (Gieres, FR). The FDA issued a Cleared decision on July 22, 2026 after a review of 110 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 Ecential Robotics devices

FDA 510(k) Submission Details - K261113

510(k) Number K261113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2026
Decision Date July 22, 2026
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 K261113.
SPINEART Navigation Instrument System
K261205 · Spineart SA · Jul 2026
TMINI Miniature Robotic System
K261024 · THINK Surgical, Inc. · Jul 2026
Ion-L Navigated Instruments
K262121 · SurGenTec, LLC · Jul 2026
OTS Hip
K261852 · Ortoma AB · Jul 2026
VERTICALE® Navigation Instruments
K253921 · Silony Medical GmbH · Jun 2026
VELYS™ Robotic-Assisted Solution
K260480 · Depuy Ireland UC · Jun 2026