# K061041: US Spine Facet Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Us Spine
- Decided: Jun 19, 2006 after 66 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: 2 generations back to K994308 (2000). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 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)
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 1.
- K031657: Stryker Spine Oasys Bone Screw, Howmedica Osteonics Corp. (2003) Summary page 1.
- K994308: Nuvasive Townley Facet Screw, Nuvasive, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K112097: Gibralt Spine Systems Facet Screw 04.0,04.5 (2011), 0 descendants of its own

## Indications for use
The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to SI (inclusive) spinal levels: 1)Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.

Source page: https://510kreport.com/device/K061041
Methodology: https://510kreport.com/methodology