# K253488: iFuse INTRA Ti™ Implant System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Feb 11, 2026 after 110 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: 23 generations back to K930834 (1993). 307 ancestors in all.
No later device cites it as a predicate yet.
0 of 308 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 5.
- K203247: iFuse-TORQ™ Implant System, SI-BONE, Inc. (2021) Summary page 5.
- K241574: iFuse TORQ® Implant System, SI-BONE, Inc. (2024) Summary page 5.
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw, Synthes USA Products, LLC (2017) Summary page 5.
- K162733: iFuse Implant System® - iFuse-3D implant, SI-BONE, Inc. (2017) Summary page 5.

## Indications for use
The iFuse INTRA Ti Implant System is intended for fusion of the sacroiliac joint for sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

Source page: https://510kreport.com/device/K253488
Methodology: https://510kreport.com/methodology