# K250247: panaSIa SI Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Jul 9, 2025 after 163 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). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233972: Camber Sacroiliac (SI) Fixation System, Camber Spine Technologies (2024) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.

## Indications for use
The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K250247
Methodology: https://510kreport.com/methodology