# K253432: DiversiVy™ Facet Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Vy Spine, LLC
- Decided: Mar 19, 2026 after 169 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 K953076 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130863: Facet Screw System, Spinal USA (2013) Summary page 6.

## Indications for use
The DiversiVy™ 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 with or without bone graft, at single or multiple levels from L1 to S1 (inclusive), for any or all of the following: Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic, Degenerative Disc Disease (DDD) 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/K253432
Methodology: https://510kreport.com/methodology