# K121850: Typhoon (TM) Facet Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Sep 20, 2012 after 87 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 K994308 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.
- K100154: Fixcet Spinal Facet Screw System, X-Spine Systems, Inc. (2010) Summary page 1.

## Indications for use
The Typhoon t " Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from Li to Si inclusive. The TyphoonTm Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of disco~genic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudloarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations. For transfacet fixation, the Typhoon m Facet Screw Fixation System is inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.

Source page: https://510kreport.com/device/K121850
Methodology: https://510kreport.com/methodology