# K173522: Solanas® Posterior Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 30, 2017 after 16 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 K003155 (2001). 113 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071380: Modification to Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2007) Summary page 4.
- K150918: PASS OCT Spinal System, Medicrea International SA (2015) Summary page 4.

## Most influential descendants
- K191185: Solanas® Posterior OCT Fixation System (2019), 4 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own

## Indications for use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas® Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods. • Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. • Spondylolisthesis • Spinal Stenosis • Fracture/Dislocation • Atlanto/Axial fracture with instability • Revision of previous cervical spine surgery • Tumors.

Source page: https://510kreport.com/device/K173522
Methodology: https://510kreport.com/methodology