HomeAustraliaKico Knee Innovation Company Pty Limited

Kico Knee Innovation Company Pty Limited

Australia · Pymble
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 3Class II 4Class III 0
plus 10 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
Class I 1IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States10 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: KICO KNEE INNOVATION COMPANY
Same-named companies — This database also contains companies with near-identical names: KICO KNEE INNOVATION COMPANY. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Australia
City
Pymble

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

ABN
78602358289
Registration status
Active
Legal form
Australian Private Company
Registered address
NSW, 2073

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12017 · K163405
12022 · K213380
12023 · K223927
12024 · K242009
22025 · K243980

FDA listed device types

Orthopedic Stereotaxic Instrument 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Orthopedic Augmented Reality 1Orthopedic Tray 1Awl 1Probe 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243980ARVIS Surgical Navigation System2025-03-21
USK243950ARVIS® Shoulder2025-01-13
USK242009360CAS Knee2024-08-08

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