# K173910: Impress SFS System

- Pathway: 510(k) (Traditional)
- Applicant: Cable Fix Medical, LLC
- Decided: Sep 14, 2018 after 266 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K792022 (1979). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031162: Smith & Nephew Orthopaedic Cabling System, Smith & Nephew, Inc. (2003) Summary page 4.
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 4.
- K953777: Synthes Wire Mount, Synthes (Usa) (1996) Summary page 4.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The Impress SFS System is indicated for general orthopaedic repair procedures. The Impress SFS System is also intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K173910
Methodology: https://510kreport.com/methodology