Cleared Traditional

K163405 - 360KS Implant Positioning System

K163405 is an FDA 510(k) clearance for 360KS Implant Positioning System, manufactured by Kico Knee Innovation Company Pty Limited. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K163405 · Kico Knee Innovation Company Pty Limited · Radiology device
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Mar 2017
Decision
106d
Days
Class 2
Risk

K163405 is an FDA 510(k) clearance for the 360KS Implant Positioning System. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Kico Knee Innovation Company Pty Limited (Pymble, AU). The FDA issued a Cleared decision on March 21, 2017 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Kico Knee Innovation Company Pty Limited devices

FDA 510(k) Submission Details - K163405

510(k) Number K163405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2016
Decision Date March 21, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 Radiology devices follow this clearance model.

Regulatory Consultant

Softwarecpr
Sandy Hedberg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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