Cleared Special

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II (K251315) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251315 · Remex Medical Corp. · Orthopedic device
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May 2025
Decision
30d
Days
Class 2
Risk

K251315 is an FDA 510(k) clearance for the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation Sy.... Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Remex Medical Corp. (Taichung, TW). The FDA issued a Cleared decision on May 29, 2025 after a review of 30 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 Remex Medical Corp. devices

Submission Details

510(k) Number K251315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2025
Decision Date May 29, 2025
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 344
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K251315.
SPINEART Navigation Instrument System
K242933 · Spineart SA · Jun 2025
Stealth™ Spine Clamps
K242464 · Medtronic Navigation, Inc. · Jun 2025
Paradigm System
K250879 · Proprio, Inc. · Jun 2025
OTS Hip
K250086 · Ortoma AB · May 2025
Altus Spine Navigation System
K243419 · Altus Partners, LLC · May 2025
Mako Total Knee Application (3.0)
K250608 · Mako Surgical Corp. · Apr 2025