Cleared Special

K231963 - REAL INTELLIGENCE™ CORI™

K231963 is an FDA 510(k) clearance for REAL INTELLIGENCE CORI, manufactured by Blue Belt Technologies, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 29-day FDA review.

K231963 · Blue Belt Technologies, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
29d
Days
Class 2
Risk

K231963 is an FDA 510(k) clearance for the REAL INTELLIGENCE™ CORI™. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Blue Belt Technologies, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 1, 2023 after a review of 29 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.

FDA 510(k) Submission Details - K231963

510(k) Number K231963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date August 01, 2023
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 444
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K231963.
Fusion Robotic Navigation System
K232413 · Alphatec Spine, Inc. · Sep 2023
CoreLink Navigation Instruments
K232116 · Corelink, LLC · Aug 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · Brainlab AG · Aug 2023
SURGIVISIO Device
K231886 · Ecential Robotics · Jul 2023
ApolloKnee
K231172 · Corin U.S.A. Limited · Jul 2023
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
K223301 · Spinecraft, LLC · Jul 2023
K231963 · REAL INTELLIGENCE™ CORI™
Download PDF FDA Summary Blue Belt Technologie…