# K090952: Zyfuse Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 14, 2009 after 102 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: 1 generation back to K083442 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083442: Corridor Fixation System, Globus Medical, Inc. (2009) Summary page 1.

## Indications for use
The ZYFUSE MT Facet Fixation 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 S1. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The ZYFUSE MT Facet Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.

Source page: https://510kreport.com/device/K090952
Methodology: https://510kreport.com/methodology