# K120597: Kompreda

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: May 3, 2013 after 430 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Cited in the summary but kept off the family tree
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Kompresa Facet Screw System is indicated for bilateral transfacet fixation and stabilization of the facet joints as an aid to fusion for the treatment of any or all of the following at the T10 to S1 (included) spinal levels: * Trauma, including spinal fractures and/or dislocation Spondylolisthesis Spondylolysis * Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity * Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). * Degeneration of the facets with instability

Source page: https://510kreport.com/device/K120597
Methodology: https://510kreport.com/methodology