# K171421: VERTICALE® Posterior Spinal Fixation System/VERTICALE® System

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Jan 10, 2018 after 240 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: 14 generations back to K853033 (1985). 79 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 5.
- K092287: Nuvasive Spherx II - Pedicle Screw System, Nuvasive, Inc. (2009) Summary page 5.

## Most influential descendants
- K201420: Republic Spine Dark Star Spinal System (2021), 2 descendants of its own
- K223096: Dark Star Deformity Pedicle Screw System (2023), 1 descendant of its own
- K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 0 descendants of its own
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own
- K223806: VERTICALE® Triangular Fixation System (2023), 0 descendants of its own

## Indications for use
The VERTICALE® System is intended to provide immobilization and stabilization of 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® System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VERTICALE® MIS System is intended for non-cervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the VERTICALE® and VERTICALE® MIS metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The subject device is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K171421
Methodology: https://510kreport.com/methodology