# K192354: Innovasis Gibralt Spine System

- Pathway: 510(k) (Special)
- Applicant: Innovasis, Inc.
- Decided: Sep 24, 2019 after 26 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: 4 generations back to K953076 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160697: Gibralt® Spine System and Gibralt® Occipital Spine System, Exactech, Inc. (2016) Summary page 4.

## Indications for use
The Innovasis Gibralt Spine 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 cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); 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 Gibralt Spine 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 Gibralt Spine System may be connected to the Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.

Source page: https://510kreport.com/device/K192354
Methodology: https://510kreport.com/methodology