# K970280: Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam Fractures

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: May 22, 1997 after 119 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K850886 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954757: Fixano D.D.S. (Double Sliding Screw), Ferguson Medical (1996) Summary page 1.
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 1.
- K955306: Omega+ Compression Screw System, Howmedica Corp. (1996) Summary page 1.
- K900584: Alta Lag Screw and Compression Screw, Howmedica Corp. (1990) Summary page 1.
- K954555: Versa-FX Femoral Fixation System, Zimmer, Inc. (1996) Summary page 1.

## Indications for use
This device is indicated for use in the fixation of per-trochanteric fractures.

Source page: https://510kreport.com/device/K970280
Methodology: https://510kreport.com/methodology