# K120390: Solafix Twist Screw Implant System, Surgical Instrument Set

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Apr 10, 2012 after 63 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K043583 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050819: Charlotte Snap-Off Screw, Wrightmedicaltechnologyinc (2005) Summary page 1.

## Indications for use
The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

Source page: https://510kreport.com/device/K120390
Methodology: https://510kreport.com/methodology