# K110197: Exactech Gibralt Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jul 15, 2011 after 172 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K853033 (1985). 21 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050979: S4 Spinal System, Aesculap, Inc. (2005) Summary page 1.
- K003780: Vertex Reconstruction System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K991089: Synthes Cervifix System, Synthes Spine (1999) Summary page 1.
- K023675: Synthes Cervifix/ Axon, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K171369: M.U.S.T. MINI Posterior Cervical Screws System (2017), 8 descendants of its own
- K200130: M.U.S.T. MINI Posterior Cervical Screws System (2020), 6 descendants of its own
- K200936: Invictus™ CT Spinal Fixation System (2020), 3 descendants of its own
- 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

## Recalls of this device
- Jan 6, 2014 · Class II · Z-1217-2014: The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.

## 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/K110197
Methodology: https://510kreport.com/methodology