# K190658: MIS Bunion Plating System

- Pathway: 510(k) (Special)
- Applicant: Crossroads Extremity Systems, LLC
- Decided: Apr 12, 2019 after 29 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: 8 generations back to K901456 (1990). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181872: MIS Bunion System, Crossroads Extremity Systems, LLC (2019) Summary page 4.

## Most influential descendants
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 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/K190658
Methodology: https://510kreport.com/methodology