# K160972: Gexfix External Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Gexfix International Corp.
- Decided: Dec 28, 2016 after 266 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
Longest line of descent: 1 generation back to K052605 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052605: External Fixation, Gexfix USA, Inc. (2005) Summary page 5.

## Most influential descendants
- K240049: LINK (TM) External Fixator (2024), 0 descendants of its own
- K172438: ARBOR External Fixation System (2018), 0 descendants of its own

## Indications for use
1) Bone fracture fixation 2) Osteotomy 3) Arthrodesis 4) Correction of deformity 5) Revision procedures where other devices have been unsuccessful 6) Bone reconstruction procedures

Source page: https://510kreport.com/device/K160972
Methodology: https://510kreport.com/methodology