Company · AU
Kico Knee Innovation Company Pty Limited
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
4recalls (3 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2025 | K243980 | ARVIS Surgical Navigation System Kico Knee Innovation Company Pty Limited, AU | SBF |
| Jan 13, 2025 | K243950 | ARVIS® Shoulder Kico Knee Innovation Company Pty, Ltd., AU | SBF |
| Aug 8, 2024 | K242009 | 360CAS Knee Kico Knee Innovation Company Pty, Ltd., AU | OLO |
| Jan 27, 2023 | K223927 | 360CAS Kico Knee Innovation Company Pty Limited, AU | OLO |
| Jan 11, 2022 | K213380 | 360CAS Kico Knee Innovation Company Pty Limited, AU | OLO |
| Mar 21, 2017 | K163405 | 360KS Implant Positioning System Kico Knee Innovation Company Pty Limited, AU | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Kico Knee Innovation Company 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 S Open, Classified |
SBF | K243950 K243980 |
| Jun 2, 2026 | Kico Knee Innovation Company Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C Open, Classified |
OLO | K203115 |
| Jun 2, 2026 | Kico Knee Innovation Company 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-2 Open, Classified |
OLO | K203115 |
| Oct 14, 2025 | Kico Knee Innovation Company 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 c Open, Classified |
SBF | K243950 |