# K062391: Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00

- Pathway: 510(k) (Traditional)
- Applicant: Triage Medical, Inc.
- Decided: Sep 14, 2006 after 29 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020411 (2002). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043351: 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N, Triage Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K082795: Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant (2008), 8 descendants of its own
- K102438: Primalok Facet Fixation System (2010), 4 descendants of its own
- K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer (2009), 3 descendants of its own
- K240085: zLOCK Lumbar Facet Fixation System (2024), 2 descendants of its own
- K101762: Viper F2 Facet Fixation System (2010), 1 descendant of its own

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-3033-2011: This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compre

## Indications for use
The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from LI to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.

Source page: https://510kreport.com/device/K062391
Methodology: https://510kreport.com/methodology