# K043289: E-Z Frame External Surgical Support Boot

- Pathway: 510(k) (Traditional)
- Applicant: Signal Medical Corp.
- Decided: Feb 11, 2005 after 74 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K130044: Sidekick EZ Frame External Fixation System (2013), 7 descendants of its own
- K153635: SALVATION (R) External Fixation System (2016), 4 descendants of its own
- K162033: SALVATION External Fixation System (2017), 3 descendants of its own
- K180832: SALVATION External Fixation System (2018), 1 descendant of its own
- K200343: FusionFrame Ring Lock System (2020), 0 descendants of its own

## Indications for use
Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis comminuted trauma Diabetic Charcot reconstruction Most foot pathology not requiring fixation above the ankle

Source page: https://510kreport.com/device/K043289
Methodology: https://510kreport.com/methodology