# K191185: Solanas® Posterior OCT Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine
- Decided: Jun 3, 2019 after 31 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 116 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 4.
- K173522: Solanas® Posterior Stabilization System, Alphatec Spine, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
The Solanas Posterior OCT Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Solanas Posterior OCT Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Solanas Posterior OCT Fixation System may be connected to the components in the Zodiac® Polyaxial Spinal Fixation System, the Arsenal® Spinal Fixation System, or the Invictus™ Spinal Fixation System offered by Alphatec Spine using the Rod to Rod Connectors or Transitional Rods.

Source page: https://510kreport.com/device/K191185
Methodology: https://510kreport.com/methodology