# K140463: Integra External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Oct 10, 2014 after 228 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890814 (1989). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093057: Biomet Vision Footring System, Ebi, L.P. (2009) Summary page 7.

## Most influential descendants
- K181630: Revolution External Plating System (2019), 1 descendant of its own
- K233025: Revolution External Plating System (2024), 0 descendants of its own
- K160830: Integra External Fixation System (2016), 0 descendants of its own

## Recalls of this device
- Jul 20, 2016 · Class II · Z-2387-2016: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
- Jul 20, 2016 · Class II · Z-2386-2016: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
- Jul 1, 2016 · Class II · Z-2296-2016: The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

## Indications for use
The Integra External Fixation System is an external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. Additional indications for the Integra External Fixation System include: • Correction of deformity • Revision procedures where other treatments or devices have been unsuccessful • Bone reconstruction procedures • Fusions and replantations of the foot • Charcot reconstruction and Lisfranc dislocations • Ankle distraction (arthrodiastasis)

Source page: https://510kreport.com/device/K140463
Methodology: https://510kreport.com/methodology