# K181872: MIS Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems, LLC
- Decided: Feb 19, 2019 after 222 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: 7 generations back to K901456 (1990). 35 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151270: CrossTIE Intraosseous Fixation System, Crossroads Extremity Systems, LLC (2015) Summary page 4.
- K153204: In2Bones Kirschner wire, In2bones Sas (2016) Summary page 4.

## Most influential descendants
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own
- K240173: Treace Medical Systems (TMC) Plating System (2024), 4 descendants of its own
- K212487: CoLink Vallux Plating System (2021), 4 descendants of its own
- K242415: TMC Compression Implant System (2024), 3 descendants of its own
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own

## Indications for use
The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Source page: https://510kreport.com/device/K181872
Methodology: https://510kreport.com/methodology