# K172260: Omni Foot Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Extremity Medical, LLC
- Decided: Nov 6, 2017 after 102 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: 13 generations back to K954385 (1996). 220 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 225 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161864: ARIX Foot System, Jeil Medical Corporation (2016) Summary page 4.
- K140397: Paralock Plating System / Tuffnek Screw, Paragon 28 (2014) Summary page 4.
- K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer, Extremity Medical, LLC (2012) Summary page 4.

## Most influential descendants
- K180808: Omni Foot Plating System (2018), 3 descendants of its own
- 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, reconstruction, or arthrodesis of the 1st Metatarsalphalangeal joint.

Source page: https://510kreport.com/device/K172260
Methodology: https://510kreport.com/methodology