Cleared Special

360CAS (K223927) - FDA 510(k) Clearance

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

K223927 · Kico Knee Innovation Company Pty Limited · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2023
Decision
28d
Days
Class 2
Risk

K223927 is an FDA 510(k) clearance for the 360CAS. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Kico Knee Innovation Company Pty Limited (Sydney, AU). The FDA issued a Cleared decision on January 27, 2023 after a review of 28 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 Kico Knee Innovation Company Pty Limited devices

Submission Details

510(k) Number K223927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2022
Decision Date January 27, 2023
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K223927.
Rosa Knee System
K230180 · Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
K223767 · Stryker Leibinger GmbH & Co KG · Feb 2023
Naviswiss Knee
K223351 · Naviswiss AG · 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
Curiteva Navigation System
K223200 · Curiteva, Inc. · Jan 2023