# K121877: Gibralt  Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Feb 12, 2013 after 229 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: 13 generations back to K003155 (2001). 95 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110353: Mountaineer Oct Spinal System, Depuy Spine, Inc. (2011)
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K041203: Summit Oct Spinal System, Depuy Spine, Inc. (2004) Summary page 1.
- K110522: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2011)
- K091365: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Soafamor Danek (2009) Summary page 1.
- K090714: Vertex Reconstruction System, Vertex Select Reconstruction System, Medtronic Sofamor Danek (2009) Summary page 1.
- K082728: Vertex Recontruction System, Vertex  Select Reconstruction System, Medtronic Sofamor Danek USA, Inc. (2009) Summary page 1.
- K090060: Nexlink Oct System, Model 7000 Series, Abbott Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K133374: Streamline Oct Occipito-Cervico-Thoracic System (2014), 3 descendants of its own
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), 2 descendants of its own
- K161498: Streamline OCT Occipito-Cervico-Thoracic System (2016), 1 descendant of its own
- K172139: Streamline OCT Occipito-Cervico-Thoracic System (2017), 0 descendants of its own

## Indications for use
When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlarito-axial fracture with instability, failed previous fusion and/or tumors. The Occipital Bone Screws are limited to occipital fixation only. The use of polyaxial screws is limited to placement in T1I-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K121877
Methodology: https://510kreport.com/methodology