# K150223: Facet-Link Stabilization Platform

- Pathway: 510(k) (Traditional)
- Applicant: Facet-Link, Inc.
- Decided: Apr 28, 2015 after 88 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: 6 generations back to K994308 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123497: Facet Screw System, Facet-Link, Inc. (2013) Summary page 4.

## Indications for use
The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following: 1. Spondylolisthesis. 2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies. 3. Degeneration of the facets with instability. The Facet-Link Facet Screw System is indicated for treatment of any or all of the following: 1. Pseudoarthrosis and failed previous fusion; 2. Spondylolisthesis; and 3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

Source page: https://510kreport.com/device/K150223
Methodology: https://510kreport.com/methodology