# K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jun 15, 2018 after 85 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: 7 generations back to K903810 (1990). 12 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141246: Life Spine Sacroiliac Joint Fixation System, Life Spine, Inc. (2015) Summary page 4.

## Most influential descendants
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System (2020), 13 descendants of its own
- K212903: SIMPACT Sacroiliac Joint Fixation System (2021), 8 descendants of its own
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System (2023), 3 descendants of its own
- K223819: SI-Cure Sacroiliac Joint Fusion System (2023), 2 descendants of its own
- K241464: ARx® SAI Implant System (2024), 1 descendant of its own

## Indications for use
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K180749
Methodology: https://510kreport.com/methodology