# K223806: VERTICALE® Triangular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Jul 6, 2023 after 199 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K853033 (1985). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System, Silony Medical GmbH (2018) Summary page 5.

## Indications for use
The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization and stabilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VERTICALE® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion. The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above. Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.

Source page: https://510kreport.com/device/K223806
Methodology: https://510kreport.com/methodology