# K253423: ToeJack MIS Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Nov 18, 2025 after 54 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: 19 generations back to K962616 (1996). 230 ancestors in all.
No later device cites it as a predicate yet.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211650: The Radian MIS Bunion System, Nvision Biomedical Technologies, Inc. (2021) Summary page 6.
- K181872: MIS Bunion System, Crossroads Extremity Systems, LLC (2019)
- K172178: Minimally Invasive Bunion Plating System, Trilliant Surgical, Ltd. (2017) Summary page 5.

## Indications for use
The ToeJack MIS Bunion 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/K253423
Methodology: https://510kreport.com/methodology