# K123218: Illico FS Facet Fixation System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 28, 2012 after 44 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: 3 generations back to K994308 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K101170: Acute Innovations Sternal Fixation System, Acute Innovations, LLC (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ILLICO®)FS System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. The ILLICO FS System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from Li to S1 inclusive. The ILLICO FS System is indicated for treatment of any or all of the following: - degenerative disc disease (ODD) as defined by back pain of discogenic origins confirmed by history and radiographic studies - degenerative disease of the facets with instability - trauma (i.e. fracture or dislocation) - spondylolisthesis - spondylolysis - pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Source page: https://510kreport.com/device/K123218
Methodology: https://510kreport.com/methodology