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Kico Knee Innovation Company: FDA-registered device maker in Frenchs Forest New South Wales, Australia, 10 510(k) clearances

Name: Kico Knee Innovation Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kico Knee Innovation Company is registered with the FDA (registration 3013552417) in Frenchs Forest New South Wales, Australia. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated January 12, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3013552417
Address: Unit 1, 25 Frenchs Forest Rd E, Frenchs Forest New South Wales, Australia, 2086
Owner or operator: Kico Knee Innovation Company (10054916)
Roles: Complaint file establishment, Manufacturer
First device listed: July 27, 2022
Registered through: 2027
Brand names listed: 360CAS, 360CAS Knee, ARVIS Surgical Navigation System, ARVIS® Shoulder, ASTRA Portal Surgical Planning System, KICo AWL, KICo Probe, KICo Tetrous Instruments Tray

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Augmented Reality	SBF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Tray	OJH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Probe	HXB	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Manufacturer	accessdata.fda.gov
Shoulder Arthroplasty Implantation System	QHE	2	Manufacturer	accessdata.fda.gov
Shoulder Prosthesis, Reverse Configuration	PHX	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 12, 2026	K251558	Precision AI Surgical Planning System (PAI-SPS)	QHE	Substantially Equivalent	Precision AI Pty, Ltd.	accessdata.fda.gov
March 21, 2025	K243980	ARVIS Surgical Navigation System	SBF	Substantially Equivalent	Kico Knee Innovation Company Pty Limited	accessdata.fda.gov
January 21, 2025	K243955	Precision AI Surgical Planning System (PAI-SPS)	QHE	Substantially Equivalent	Precision AI Pty, Ltd.	accessdata.fda.gov
January 13, 2025	K243950	ARVIS® Shoulder	SBF	Substantially Equivalent	Kico Knee Innovation Company Pty, Ltd.	accessdata.fda.gov
August 8, 2024	K242009	360CAS Knee	OLO	Substantially Equivalent	Kico Knee Innovation Company Pty, Ltd.	accessdata.fda.gov
August 5, 2024	K233992	Precision AI Surgical Planning System (PAI-SPS)	QHE	Substantially Equivalent	Precision AI Pty, Ltd.	accessdata.fda.gov
April 29, 2024	K240062	ARVIS® Shoulder	OLO	Substantially Equivalent	Insight Medical Systems, Inc.	accessdata.fda.gov
January 27, 2023	K223927	360CAS	OLO	Substantially Equivalent	Kico Knee Innovation Company Pty Limited	accessdata.fda.gov
January 11, 2022	K213380	360CAS	OLO	Substantially Equivalent	Kico Knee Innovation Company Pty Limited	accessdata.fda.gov
July 14, 2021	K203115	ARVIS Surgical Navigation System	OLO	Substantially Equivalent	Insight Medical Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 13, 2026	99372	Class II	Ongoing	Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.	Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing	accessdata.fda.gov
April 23, 2026	98804	Class II	Ongoing	Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600, Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E	The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.	accessdata.fda.gov
September 19, 2025	97618	Class II	Ongoing	Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled n	Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.	accessdata.fda.gov

Compare with other makers

Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.