# K090343: Sentinel Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Aug 11, 2009 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: 2 generations back to K023675 (2002). 6 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070573: Synapse System, Synthes Spine Co.Lp (2007) Summary page 1.
- K043229: Modification to Altius Oct System, Interpore Cross Intl. (2004) Summary page 1.
- K032394: Stryker Spine Oasys System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K010681: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own
- K151196: Nautilus Spinal System (2015), 12 descendants of its own
- K191575: ARx Spinal System (2019), 10 descendants of its own
- K200070: ARx Spinal System (2020), 9 descendants of its own
- K203163: ARx Illiac Spinal Screw System (2020), 5 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal 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 the 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 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/K090343
Methodology: https://510kreport.com/methodology