# K020411: Nuvasive Triad Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Mar 12, 2002 after 33 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
No predicates in its family tree.
48 later devices descend from it; 11 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NuVasive™ Percutaneous Transfacet/Intrapedicular Screw: named in the summary without a submission number

## Most influential descendants
- K092568: Spartan S3 Facet System (2009), 29 descendants of its own
- K052043: 3.8MM CS Facet Compression Device (2005), 27 descendants of its own
- K120340: Venus Facet Screw System (2012), 26 descendants of its own
- K163374: ALLY™ Facet Screws (2017), 18 descendants of its own
- K043351: 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N (2005), 11 descendants of its own

## Indications for use
The NuVasive™ Triad™ Facet Screw System is intended 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 NuVasive™ Triad™ Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 for the 3.5mm screws, and from L1 to S1 for the 4.5mm screws. The Triad™ Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoarthrosis and failed previous fusion; (b) spondylolisthesis; (c) spondylolysis; (d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; (e) degeneration of the facets with instability; and (g) fracture. The NuVasive™ Triad™ Facet Screw System is intended for conventional or percutaneous surgical placement.

Source page: https://510kreport.com/device/K020411
Methodology: https://510kreport.com/methodology