# K211650: The Radian MIS Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Nov 24, 2021 after 180 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: 18 generations back to K962616 (1996). 229 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212487: CoLink Vallux Plating System, In2bones USA, LLC (2021). Cleared while this submission was under review Summary page 5.
- K172178: Minimally Invasive Bunion Plating System, Trilliant Surgical, Ltd. (2017) Summary page 5.
- K181872: MIS Bunion System, Crossroads Extremity Systems, LLC (2019) Summary page 5.

## 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
- K253423: ToeJack MIS Bunion System (2025), 0 descendants of its own

## Indications for use
The Radian 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/K211650
Methodology: https://510kreport.com/methodology