# K162266: The Cranial Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: May 1, 2017 after 263 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: 18 generations back to K040583 (2004). 336 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 338 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Globus Medical, Inc. (2016). Cleared while this submission was under review Summary page 4.
- K142253: SOLSTICE OCT System, Life Spine, Inc. (2015) Summary page 4.
- K090343: Sentinel Spinal System, Life Spine (2009) Summary page 4.
- K111076: Solanas Avalon Posterior Fixation System, Alphatec Spine, Inc. (2011) Summary page 4.
- K160697: Gibralt® Spine System and Gibralt® Occipital Spine System, Exactech, Inc. (2016) Summary page 4.

## Most influential descendants
- K200896: Solstice CCI (2020), 0 descendants of its own

## Indications for use
The Cranial Fusion System 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 Cranial Fusion 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 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 Cranial Fusion System 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/K162266
Methodology: https://510kreport.com/methodology