# K123497: Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Facet-Link, Inc.
- Decided: Feb 28, 2013 after 107 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: 5 generations back to K994308 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101284: Facet Screw System, Nuvasive, Inc. (2010) Summary page 1.
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001)

## Most influential descendants
- K150223: Facet-Link Stabilization Platform (2015), 0 descendants of its own

## Indications for use
The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are: Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar-facet fixation - The screws are inserted bilaterally 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 inferior pedicle. The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S51 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylofisthesis; and (c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies. The Facet-Link Facet Screw System is intended for conventional surgical placement.

Source page: https://510kreport.com/device/K123497
Methodology: https://510kreport.com/methodology