# K173198: Facet Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Jan 3, 2018 after 93 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: 2 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)
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 4.
- K121551: Resolute Facet Screw System, Neurostructures, LLC (2012) Summary page 4.
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 4.

## Indications for use
The Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw Fixation System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). 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 Facet Screw Fixation System is indicated for treatment for any or all of the following: Spondylolisthesis Spondylolysis Pseudoarthrosis or failed previous fusions which are symptomatic Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability Trauma including spinal fractures and/or dislocations

Source page: https://510kreport.com/device/K173198
Methodology: https://510kreport.com/methodology