# K112097: Gibralt Spine Systems Facet Screw 04.0,04.5

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Nov 21, 2011 after 122 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.
- K092568: Spartan S3 Facet System, Amendia, Inc. (2009) Summary page 1.
- K083442: Corridor Fixation System, Globus Medical, Inc. (2009) Summary page 1.
- K061041: US Spine Facet Fixation System, Us Spine (2006) Summary page 1.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Gibrait Spine System Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

Source page: https://510kreport.com/device/K112097
Methodology: https://510kreport.com/methodology