# K200896: Solstice CCI

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Apr 28, 2020 after 25 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: 19 generations back to K040583 (2004). 340 ancestors in all.
No later device cites it as a predicate yet.
0 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162266: The Cranial Fusion System, Life Spine, Inc. (2017) Summary page 4.
- K142253: SOLSTICE OCT System, Life Spine, Inc. (2015) Summary page 4.
- K170804: The Solstice OCT System, Life Spine, Inc. (2017) Summary page 4.
- K180025: Centurion POCT System, Orthofix, Inc. (2018) Summary page 4.

## Indications for use
Solstice CCI is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic 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 Solstice CCI 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 advanced 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 Solstice CCI may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

Source page: https://510kreport.com/device/K200896
Methodology: https://510kreport.com/methodology