# K140645: Gibralt Rod-to-Rod Cross Connectors

- Pathway: 510(k) (Special)
- Applicant: Exactech Sarasota
- Decided: Apr 11, 2014 after 29 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: 10 generations back to K853033 (1985). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110197: Exactech Gibralt Spinal System, Exactech, Inc. (2011)

## Most influential descendants
- K152211: PCT System (2015), 0 descendants of its own

## Indications for use
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal 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, failed previous fusion and/or tumors. 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 (C3-T3) spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine. This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.

Source page: https://510kreport.com/device/K140645
Methodology: https://510kreport.com/methodology