# K111076: Solanas Avalon Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jul 12, 2011 after 85 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: 13 generations back to K003155 (2001). 97 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093434: Vertex Reconstruction System and Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 1.
- K080394: Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System, Blackstone Medical, Inc. (2008) Summary page 1.
- K071380: Modification to Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2007) Summary page 1.

## Most influential descendants
- K182837: M.U.S.T. Mini Extension (2019), 1 descendant of its own
- K162266: The Cranial Fusion System (2017), 1 descendant of its own
- K203125: Invictus™ OCT Spinal Fixation System (2020), 0 descendants of its own
- K203149: M.U.S.T. MINI Posterior Cervical Screws System (2020), 0 descendants of its own
- K200896: Solstice CCI (2020), 0 descendants of its own

## Indications for use
The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for anchoring of the system. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the Solanas Posterior Fixation 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. However, the components of the SOLANAS AVALON Posterior Fixation System are not intended to work with the Zodiac System. It is intended for the following: 1. Degenerative disc disease (DDD), 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. Atlanto/Axial fracture with instability. 6. Revision of previous cervical spine surgery. 7. Tumors. 8. Occipito-cervical dislocation.

Source page: https://510kreport.com/device/K111076
Methodology: https://510kreport.com/methodology