# K052043: 3.8MM CS Facet Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Triage Medical, Inc.
- Decided: Oct 17, 2005 after 81 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: 1 generation back to K020411 (2002). 1 ancestor in all.
27 later devices descend from it; 2 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)
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 1.

## Most influential descendants
- K120340: Venus Facet Screw System (2012), 26 descendants of its own
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K211855: Ion Facet Screw System (2022), 10 descendants of its own
- K230840: PMT Facet Fixation System, Lumbar (PMT FFS-LX) (2023), 9 descendants of its own
- K183589: PMT Facet Screw (2019), 8 descendants of its own

## Indications for use
The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to SI.

Source page: https://510kreport.com/device/K052043
Methodology: https://510kreport.com/methodology