# K172178: Minimally Invasive Bunion Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Nov 16, 2017 after 120 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: 12 generations back to K954385 (1996). 38 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121452: Gridlock Plating System, Trilliant Surgical, Ltd. (2012) Summary page 4.
- K121437: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.

## Most influential descendants
- K211650: The Radian MIS Bunion System (2021), 3 descendants of its own
- 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 Minimally Invasive 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/K172178
Methodology: https://510kreport.com/methodology