# K250315: Ronavis – FX (FX-001)

- Pathway: 510(k) (Traditional)
- Applicant: AIRS, Inc.
- Decided: Aug 1, 2025 after 178 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961522 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061493: Apex Pins, Stryker Howmedica Osteonics (2006) Summary page 5.
- K040701: Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws, Synthes (Usa) (2004) Summary page 5.
- K182171: SMV Scientific K-Wire and Pins, Summit Medventures (2018) Summary page 5.

## Indications for use
The RONAVIS-FX is intended to be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system and for temporary bone stabilization (<24 hours) of bone fragments in extremity and orthopedic procedures.

Source page: https://510kreport.com/device/K250315
Methodology: https://510kreport.com/methodology