Cleared Special

360CAS Knee (K242009) - FDA 510(k) Clearance

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

K242009 · Kico Knee Innovation Company Pty, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
29d
Days
Class 2
Risk

K242009 is an FDA 510(k) clearance for the 360CAS Knee. 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, Ltd. (Frenchs Forest, AU). The FDA issued a Cleared decision on August 8, 2024 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.

View all Kico Knee Innovation Company Pty, Ltd. devices

Submission Details

510(k) Number K242009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2024
Decision Date August 08, 2024
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.

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 K242009.
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K241517 · Stryker Leibinger GmbH & Co KG · Aug 2024
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K242264 · THINK Surgical, Inc. · Aug 2024
SPINEART Navigation Instrument System
K241644 · Spineart SA · Aug 2024
Bendini Cloud Application
K233706 · Nuvasive · Aug 2024
Spine Navigation System
K233725 · Medivis, Inc. · Jul 2024