# K101284: Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Jul 15, 2010 after 69 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: 4 generations back to K994308 (2000). 9 ancestors in all.
2 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)
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 1.
- K020411: Nuvasive Triad Facet Screw System, Nuvasive, Inc. (2002) Summary page 1.
- K092464: Spineology Facet Screw, Spineology, Inc. (2009) Summary page 1.
- K073515: TRANS1 Facet Screw, Trans1 Incorporated (2008) Summary page 1.

## Most influential descendants
- K123497: Facet Screw System (2013), 1 descendant of its own
- K150223: Facet-Link Stabilization Platform (2015), 0 descendants of its own

## Indications for use
The Nu Vasive®O Facet Screw System is intended to stabilize the spine as an aid to ifusion through immobilization of the facet joints. The NluVasive Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to SI (inclusive). The Facet Screw System is indicated for treatment of any or all of the following: (a) pseudoartlnosis 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 Facet Screw System is intended for conventional or percutaneous surgical placement.

Source page: https://510kreport.com/device/K101284
Methodology: https://510kreport.com/methodology