# K130863: Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Aug 9, 2013 after 134 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 K953076 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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 2.

## Most influential descendants
- K253432: DiversiVy™ Facet Screw System (2026), 0 descendants of its own

## Indications for use
The Spinal USA 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 with or without bone graft, at single or multiple levels, of any or all of the following spinal levels Li to S1 (inclusive): 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 disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K130863
Methodology: https://510kreport.com/methodology