# K160830: Integra External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ascension Orthopedics
- Decided: Jul 6, 2016 after 103 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890814 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140463: Integra External Fixation System, Ascension Orthopedic (2014) Summary page 6.

## 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.

## 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/K160830
Methodology: https://510kreport.com/methodology