# K120998: Solstice Cross Connector

- Pathway: 510(k) (Special)
- Applicant: Life Spine
- Decided: Oct 1, 2012 after 182 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: 14 generations back to K003155 (2001). 109 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 111 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). Our reading of the summary gave K093043, FDA’s number for Zirconia Syringe Needle (Kuo Tai Hospital Managements & Consultant Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “The Sentinel Spinal System”.
- K083073: Theken Atoll Cervico-Thoracic System, Theken Spine, LLC (2009) Summary page 1.
- K113593: Nextgen Altius Oct System, Biomet Spine (Aka Ebi, LLC) (2012). Cleared while this submission was under review
- K073654: Blackstone Ascent Poct System Parallel Rod Connector, Blackstone Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K150229: SOLSTICE OCT System (2015), 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 polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The hooks, rods, and cross connectors 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/K120998
Methodology: https://510kreport.com/methodology