# K131119: Solanas Posterior Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: May 21, 2013 after 29 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K853033 (1985). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 1.
- K071380: Modification to Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2007) Summary page 1.

## Recalls of this device
- Jun 26, 2014 · Class II · Z-2092-2014: Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.

## Indications for use
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at Cl-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed 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 1. Degenerative disc disease (DOD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 2. Spondylolisthesis 3. Spinal stenosis 4. Fracture/Dislocation 5. AtlantolAxial fracture with instability 6. Revision of previous cervical spine surgery 7. Tumors

Source page: https://510kreport.com/device/K131119
Methodology: https://510kreport.com/methodology