Cleared Traditional

CUVIS-spine (K223558) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223558 · Curexo, Inc. · Orthopedic device
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Jun 2023
Decision
206d
Days
Class 2
Risk

K223558 is an FDA 510(k) clearance for the CUVIS-spine. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Curexo, Inc. (Seoul, KR). The FDA issued a Cleared decision on June 22, 2023 after a review of 206 days - an extended review cycle.

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 Curexo, Inc. devices

Submission Details

510(k) Number K223558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2022
Decision Date June 22, 2023
Days to Decision 206 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 122d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K223558.
VADER® Pedicle System Navigated Instruments
K230861 · Icotec AG · Jun 2023
RI.KNEE Adjustable Tibia Cut Guide
K230876 · Enztec Limited · Jun 2023
EUROPA™ Navigated Instruments
K230369 · MiRus, LLC · Jun 2023
CD Horizon™ Spinal System
K231184 · Medtronic Sofamor Danek USA, Inc. · May 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · Precision Spine, Inc. · May 2023
Rod Registration Frame
K230989 · Nu Vasive, Incorporated · May 2023