# K211855: Ion Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Feb 25, 2022 after 254 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). 18 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163374: ALLY™ Facet Screws, Providence Medical Technology, Inc. (2017) Summary page 4.
- K132126: Spectrum Spine Fenestrated Facet Screw System, Spectrum Spine, LLC (2013) Summary page 4.

## Most influential descendants
- 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
- K243265: Ion 3D (2024), 1 descendant of its own

## Indications for use
The Ion Facet Screw System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: • Spondylolisthesis • Spondylolysis • Pseudoarthrosis or failed previous fusions which are symptomatic • Degenerative disc disease (DDD) 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 facet with instability The system is intended for use with bone graft material.

Source page: https://510kreport.com/device/K211855
Methodology: https://510kreport.com/methodology