# K142253: SOLSTICE OCT System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Apr 23, 2015 after 252 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K853033 (1985). 26 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090343: Sentinel Spinal System, Life Spine (2009) Summary page 4.
- K083863: Theken Atoll Oct Spinal System, Theken Spine, LLC (2009) Summary page 4.

## Most influential descendants
- K162266: The Cranial Fusion System (2017), 1 descendant of its own
- K200896: Solstice CCI (2020), 0 descendants of its own
- K173047: The Solstice OCT System (2018), 0 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by 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; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine. The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Source page: https://510kreport.com/device/K142253
Methodology: https://510kreport.com/methodology