510(k) K243950 · SBF Orthopedic Augmented Reality
ARVIS® Shoulder
| Applicant | Kico Knee Innovation Company Pty, Ltd., Frenchs Forest, AU |
| Decision | Substantially Equivalent, Jan 13, 2025 |
| Received | Dec 23, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243950
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.