# K052605: External Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Gexfix USA, Inc.
- Decided: Nov 10, 2005 after 50 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K160972: Gexfix External Fixation (2016), 2 descendants of its own
- K240049: LINK (TM) External Fixator (2024), 0 descendants of its own
- K172438: ARBOR External Fixation System (2018), 0 descendants of its own
- K082833: NBX - Non-Bridging External Fixator - Shoulder (2009), 0 descendants of its own

## Indications for use
1) BONE FRACTURE FIXATION 2) OSTEOTOMY 3) ARTHODESIS 4) CORRECTION OF DEFORMITY 5. REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE. UNSUCCESSFUL 6) BONE RECONSTRUCTION PROCEDURES

Source page: https://510kreport.com/device/K052605
Methodology: https://510kreport.com/methodology