# K242431: Omnia Medical PsiF DNA™ System

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Jun 6, 2025 after 294 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 128 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232149: BowTie™ SI Joint Fusion System, Sail Fusion, LLC (2024) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Most influential descendants
- K250894: Eminent Spine Posterior SI System (2025), 0 descendants of its own

## Indications for use
The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.

Source page: https://510kreport.com/device/K242431
Methodology: https://510kreport.com/methodology