Class Class II
RONAVIS – FX (FX-001) (K250315)
Description
RONAVIS – FX (FX-001) by AIRS, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250315
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeHTY
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250315
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. RONAVIS – FX (FX-001) (K250315) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018 |
| K061493 | APEX PINS | Stryker Howmedica Osteonics | 2006 |
| K040701 | SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS | Synthes (Usa) | 2004 |
Trace the full predicate network for K250315
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.