# K132126: Spectrum Spine Fenestrated Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Spine, LLC
- Decided: Oct 28, 2013 after 110 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). 9 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.
- K123932: Zygafix Spinal Facet Screw System, X-Spine Systems, Inc. (2013) Summary page 1.

## Most influential descendants
- 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
- K252153: FFX Facet Fixation System (2025), 2 descendants of its own
- K241416: Ion 3D (2024), 2 descendants of its own

## Indications for use
The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at Li-Si (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudlarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (ODD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

Source page: https://510kreport.com/device/K132126
Methodology: https://510kreport.com/methodology