# K121551: Resolute Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, LLC
- Decided: Oct 23, 2012 after 151 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K100264: T-Form Extremity Immobilizer, Model RT-6060, Bionix Development Corp. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K090924: Capture MIS Facet Screw System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K173198: Facet Screw Fixation System (2018), 0 descendants of its own

## Indications for use
The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the Llito Si (inclusive) spinal levels: Spondylolisthesis, Pseudloarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (ODD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

Source page: https://510kreport.com/device/K121551
Methodology: https://510kreport.com/methodology