# K110472: SI-Fix Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: May 29, 2012 after 466 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: 6 generations back to K903810 (1990). 20 ancestors in all.
92 later devices descend from it; 7 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110838: Ifuse Implant System, SI-BONE, Inc. (2011). Cleared while this submission was under review Summary page 2.
- K092375: Modification to SI Joint Fusion System, SI-BONE, Inc. (2009) Summary page 2.
- K080398: SI Joint Fusion System, SI-BONE, Inc. (2008) Summary page 2.
- K102903: Pioneer Cannulated Screw System, Pioneer Surgical Technology, Inc. (2010) Summary page 2.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011). Cleared while this submission was under review
- K111801: Simmetry (TM) Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2011). Cleared while this submission was under review
- K051296: Sijf Cannulated Screw System, Depuy Spine, Inc. (2005) Summary page 2.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 2.
- K914004: Alphatec Cannulated Bone Screws, Alphatec Mfg., Inc. (1991) Summary page 2.

## Most influential descendants
- 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 (2016), 79 descendants of its own
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (2018), 30 descendants of its own
- K191748: Genesys Spine Sacroiliac Joint Fusion System (2019), 22 descendants of its own
- K203247: iFuse-TORQ™ Implant System (2021), 17 descendants of its own
- K213667: iFuse-TORQ® Implant System (2022), 15 descendants of its own

## Indications for use
The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fuision for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

Source page: https://510kreport.com/device/K110472
Methodology: https://510kreport.com/methodology