# K143365: Eminent Foot Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Eminent Spine
- Decided: Mar 30, 2015 after 126 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: 11 generations back to K962616 (1996). 156 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131722: I.T.S. Extremity Fixation Systems, I.T.S. GmbH (2013) Summary page 6.
- K071105: Osteomed Calcaneal Plate and Screw Fixation System, Osteomed LP (2007) Summary page 6.
- K091614: Osteomed Foot Plating System, Osteomed LP (2009) Summary page 6.
- K131445: Osteomed Extremilock Foot Plating System, Osteomed LP (2013) Summary page 6.
- K133437: 1ST MTP Plate, Osteomed (2013) Summary page 6.

## Most influential descendants
- K152548: AXI+LINE Proximal Bunion Correction System (2015), 0 descendants of its own

## Indications for use
The Eminent Foot Plate System is intended for fixation of fractures, osteotomies, non-unions, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle.

Source page: https://510kreport.com/device/K143365
Methodology: https://510kreport.com/methodology