# K191344: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 3, 2019 after 136 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 K063049 (2006). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.

## Most influential descendants
- K210754: Cannulated Fasteners and Nuts (2021), 3 descendants of its own
- K220937: Arthrex Mini Fragment System (2022), 2 descendants of its own
- K211290: Cannulated Fasteners and Nuts (2021), 2 descendants of its own
- K242554: Arthrex VAL and VAL KreuLock™ Compression Screw System (2024), 1 descendant of its own
- K260809: Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System (2026), 0 descendants of its own

## Indications for use
The Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Plates are to be used with the Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid). The Arthrex Mini Comprehensive Fixation System Screws (2.0-2.4 mm solid) are intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The Arthrex Mini Comprehensive Fixation System Screws are to be used with the Arthrex Mini Comprehensive Fixation System Plates (2.0-2.4 mm).

Source page: https://510kreport.com/device/K191344
Methodology: https://510kreport.com/methodology