# K092464: Spineology Facet Screw

- Pathway: 510(k) (Traditional)
- Applicant: Spineology, Inc.
- Decided: Nov 9, 2009 after 90 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). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 1.
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.

## Most influential descendants
- K101284: Facet Screw System (2010), 2 descendants of its own
- K123497: Facet Screw System (2013), 1 descendant of its own
- K101762: Viper F2 Facet Fixation System (2010), 1 descendant of its own
- K192281: AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System (2019), 0 descendants of its own
- K150223: Facet-Link Stabilization Platform (2015), 0 descendants of its own

## Indications for use
The Spineology Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the LI to SI (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic 'Studies and/or degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K092464
Methodology: https://510kreport.com/methodology