Cleared Traditional

Curiteva Navigation System (K223200) - FDA 510(k) Clearance

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

K223200 · Curiteva, Inc. · Orthopedic device
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Jan 2023
Decision
85d
Days
Class 2
Risk

K223200 is an FDA 510(k) clearance for the Curiteva Navigation 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 Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on January 6, 2023 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Curiteva, Inc. devices

Submission Details

510(k) Number K223200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2022
Decision Date January 06, 2023
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K223200.
360CAS
K223927 · Kico Knee Innovation Company Pty Limited · Jan 2023
Blueprint Mixed Reality system
K222510 · Tornier S.A.S. · Jan 2023
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
K223108 · Medos International SARL · Jan 2023
VERTICALE® Navigation Instruments
K223649 · Silony Medical GmbH · Dec 2022
RobPath® Total Hip Application
K220774 · Hangzhou Lancet Robotics Co., Ltd. · Dec 2022
SeaSpine 7D Navigation Instruments
K222753 · SeaSpine Orthopedics Corporation · Dec 2022