Class Class II
ARVIS® Shoulder (K243950)
Description
ARVIS® Shoulder by Kico Knee Innovation Company Pty, Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243950
Clearance Date2025-01-13
Clearance TypeSpecial
Product CodeSBF
Regulation Number882.4560
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243950
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ARVIS® Shoulder (K243950) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. | 2024 |
Trace the full predicate network for K243950
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.