Class Class II
ARIX Humerus System (K230938)
Description
ARIX Humerus System by Jeil Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230938
Clearance Date2023-05-03
Clearance TypeSpecial
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230938
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. ARIX Humerus System (K230938) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K172008 | ARIX Humerus System | Jeil Medical Corporation | 2017 |
| K152158 | ARIX Ankle System | Jeil Medical Corporation | 2015 |
Trace the full predicate network for K230938
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.