# K131417: Facet Fixx

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine, LLC
- Decided: Jul 12, 2013 after 57 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: 3 generations back to K994308 (2000). 6 ancestors in all.
130 later devices descend from it; 3 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.
- K953076: Townley Facet/Pedicular Screw Plating System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K003928: Townley Transfacetpedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.
- K021705: Modification to Townley Transfacepedicular Screw Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.

## Most influential descendants
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own

## Indications for use
The Facet Fixx System is intended to stabilize the spine as an aid. to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to Si inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: * Degenerative disc disease (DOD) as defined by back pain of discogenic origins confirmed by history and radiographic studies * Degenerative disease of the facets with instability * Trauma (i.e. fracture or dislocation) * Spondylolisthesis * Spondylolysis * Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity

Source page: https://510kreport.com/device/K131417
Methodology: https://510kreport.com/methodology