# K090865: Life Spine Facet Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Jun 26, 2009 after 88 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Life Spine Facet Screw Spinal System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spondylosis, fracture, degeneration of the facets with instability, pseudoarthrosis, and failed previous fusion. The Life Spine Facet Screw System, when properly used, 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 Life Spine Facet Screw System 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/K090865
Methodology: https://510kreport.com/methodology