# K180808: Omni Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: May 22, 2018 after 55 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: 14 generations back to K954385 (1996). 234 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 238 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172260: Omni Foot Plating System, Extremity Medical, LLC (2017) Summary page 4.
- K170780: ARIX Foot System (2.3/2.8), Jeil Medical Corporation (2017) Summary page 4.
- K161864: ARIX Foot System, Jeil Medical Corporation (2016) Summary page 4.
- K143188: 3.Omm Biomet Cannulated Screw System, Biomet Manufacturing Corp (2014) Summary page 4.

## Most influential descendants
- K212297: Omni Foot and Ankle Plating System (2021), 1 descendant of its own
- K221362: Omni Foot and Ankle Plating System (2022), 0 descendants of its own
- K192592: Axis Plating System (2019), 0 descendants of its own

## Indications for use
The Omni Foot Plating System is intended for use in internal fixation of arthrodeses, osteotomies, fractures and nonunions of the small bones of the foot & ankle including the fore-, mid-, and hind foot and ankle applications.

Source page: https://510kreport.com/device/K180808
Methodology: https://510kreport.com/methodology