# K193156: Arthrex Mini Comprehensive Fixation System - 1.0mm Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 10, 2020 after 88 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: 1 generation back to K030310 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.

## Indications for use
The Arthrex Mini Comprehensive Fixation System Screws (1.0 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand and wrist.

Source page: https://510kreport.com/device/K193156
Methodology: https://510kreport.com/methodology