# K220937: Arthrex Mini Fragment System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 29, 2022 after 90 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: 15 generations back to K792022 (1979). 176 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System, Stryker GmbH (2019) Summary page 4.
- K191344: Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module, Arthrex, Inc. (2019) Summary page 4.
- K140814: Evos Mini-Fragment Plating System, Smith & Nephew, Inc. (2014) Summary page 4.

## Most influential descendants
- 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 Fragment System is indicated for fracture fixation, reconstruction, replantation, stabilization, reduction, fusions, osteotomies, mal-unions, and non-unions of small bones and small bone fragments including normal and osteopenic bones in adult and adolescent (12 - 21 year) patients. The system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Source page: https://510kreport.com/device/K220937
Methodology: https://510kreport.com/methodology