Class Class II
ARIX Femur Nail System (K242247)
Description
ARIX Femur Nail System by Jeil Medical Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242247
Clearance Date2025-04-22
Clearance TypeTraditional
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242247
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 Femur Nail System (K242247) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212266 | FIX-C PEEK Anterior Cervical Interbody System | Jeil Medical Corporation | 2021 |
| K200869 | Gamma3 System | Stryker Trauma GmbH | 2020 |
Trace the full predicate network for K242247
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.