# K123932: Zygafix Spinal Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: May 1, 2013 after 132 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: 4 generations back to K994308 (2000). 5 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100154: Fixcet Spinal Facet Screw System, X-Spine Systems, Inc. (2010) Summary page 2.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 2.

## Most influential descendants
- K132126: Spectrum Spine Fenestrated Facet Screw System (2013), 11 descendants of its own
- K211855: Ion Facet Screw System (2022), 10 descendants of its own
- K232468: SC Medica FFX (2024), 3 descendants of its own
- K240086: Ion 3D (2024), 3 descendants of its own
- K180729: FaSet Fixation System (2018), 3 descendants of its own

## Indications for use
The X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (LI to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the Li to Si (inclusive) spinal levels: * Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), " Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm, *Trauma (i.e., fractures and/or dislocations), *Spondylolisthesis, *Spondylolysis, *Pseudloarthrosis and/or failed previous fusions.

Source page: https://510kreport.com/device/K123932
Methodology: https://510kreport.com/methodology