# K043351: 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N

- Pathway: 510(k) (Traditional)
- Applicant: Triage Medical, Inc.
- Decided: Feb 18, 2005 after 74 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: 1 generation back to K020411 (2002). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 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
- K062391: Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00 (2006), 9 descendants of its own
- 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

## Recalls of this device
- Mar 15, 2011 · Not classified · Z-3034-2011: 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 BONE-LOK® Facet Screw 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 BONE-LOK® Facet Screw 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 BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.

Source page: https://510kreport.com/device/K043351
Methodology: https://510kreport.com/methodology