# K254280: F.A.S.T Screw

- Pathway: 510(k) (Traditional)
- Applicant: Steps Ortho
- Decided: Sep 21, 2026 after 265 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: 13 generations back to K000684 (2000). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160174: I.B.S. 2.0 Osteosynthesis screw, In2bones Sas (2016) Summary page 5.
- K131920: Stabilization Screw, In2bones Sas (2014) Summary page 5.
- K170594: I.B.S. osteosynthesis screws, In2bones Sas (2017) Summary page 5.
- K231236: IBS-B MIS Beveled Screw System, In2bones USA, LLC (2023) Summary page 5.

## Indications for use
F.A.S.T® Screws are intended for the fixation of arthrodesis, osteotomies or fractures of bones in the foot and ankle.

Source page: https://510kreport.com/device/K254280
Methodology: https://510kreport.com/methodology