KICO KNEE INNOVATION COMPANY

FDA Device Registration & Listing · Frenchs Forest New South Wales, AU · Registration 3013552417

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013552417
FEI Number
3013552417
Entity Name
KICO KNEE INNOVATION COMPANY
City/State/Country
Frenchs Forest New South Wales, AU
Establishment Address
Unit 1, 25 Frenchs Forest Rd E, Frenchs Forest New South Wales 2086, AU
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Kico Knee Innovation Company (Owner Number: 10054916)
Owner / Operator Contact Address
Unit 1, 25 Frenchs Forest Rd E, Frenchs Forest, AU-NSW 2086, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243980
PMA Number
N/A

All Registered Proprietary Names

ARVIS Surgical Navigation System 360CAS 360CAS KICo Probe ARVIS® Shoulder KICo AWL KICo Tetrous Instruments Tray ARVIS Surgical Navigation System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-07-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-10-15
HXB Probe Orthopedic Class 1 888.4540 2023-06-30
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-12-12
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-12-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-12
HWJ Awl Orthopedic Class 1 888.4540 2023-06-29
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2024-04-22
SBF Orthopedic Augmented Reality Neurology Class 2 882.4560 2025-11-16

Official Correspondent

Danyon Munro

US Agent Details

Sherri Mellingen Business: Encore Medical, L.P. Email: Sherri.Mellingen@enovis.com Phone: (952) 9136383

Related Public Records

Same Entity

Kico Knee Innovation Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3019878658 INSIGHT MEDICAL SYSTEMS, INC Austin, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013552417. Last updated year: 2026. Please use registration number 3013552417 when referencing this establishment in official correspondence.
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