# K221362: Omni Foot and Ankle Plating System

- Pathway: 510(k) (Special)
- Applicant: Exremity Medical, LLC
- Decided: Jun 10, 2022 after 30 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: 16 generations back to K954385 (1996). 300 ancestors in all.
No later device cites it as a predicate yet.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212297: Omni Foot and Ankle Plating System, Extremity Medical, LLC (2021) Summary page 4.
- K170780: ARIX Foot System (2.3/2.8), Jeil Medical Corporation (2017) Summary page 4.
- K081934: Extremity Medical Compression Screw, Extremity Medical, LLC (2008) Summary page 4.

## Indications for use
The Omni Foot and Ankle Plating System is intended for use in internal fixation of arthrodesis, 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/K221362
Methodology: https://510kreport.com/methodology