# K191326: Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 15, 2019 after 152 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 Plates (1.4-1.6 mm) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid). The Arthrex Mini Comprehensive Fixation System Screws (1.4-1.6 mm solid) are intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones. The Arthrex Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (1.4-1.6 mm).

Source page: https://510kreport.com/device/K191326
Methodology: https://510kreport.com/methodology