# K101364: Lanx Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Lanx, Inc.
- Decided: Aug 16, 2010 after 94 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 K020411 (2002). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 1.
- K083442: Corridor Fixation System, Globus Medical, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K010323: NuVasive Facet Screw. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System (2020), 0 descendants of its own
- K113011: Spartan S3 Facet System (2011), 0 descendants of its own

## Indications for use
The Lanx Facet 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 C2 to S1 for 3.5mm and 4.0mmn screws .and from LI to SI for 4.5mm screws. 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 Lanx Facet Screw 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/K101364
Methodology: https://510kreport.com/methodology