# K243865: AERO MIS Facet Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Spine
- Decided: Mar 24, 2025 after 97 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: 7 generations back to K994308 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211855: Ion Facet Screw System, SurGenTec, LLC (2022) Summary page 6.

## Indications for use
The AERO MIS Facet Fusion System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: - Spondylolisthesis, - Spondylolysis, - Pseudoarthrosis or failed previous fusions which are symptomatic, or - Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability. The system is intended for use with bone graft material.

Source page: https://510kreport.com/device/K243865
Methodology: https://510kreport.com/methodology