# K212903: SIMPACT Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 15, 2021 after 93 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: 17 generations back to K930834 (1993). 137 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 4.
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2020) Summary page 4.
- K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2018) Summary page 4.
- K141246: Life Spine Sacroiliac Joint Fixation System, Life Spine, Inc. (2015) Summary page 4.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 4.

## Most influential descendants
- 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
- K240505: Eminent Spine SI Screw System (2024), 1 descendant of its own
- K231951: SI-Cure Sacroiliac Joint Fusion System (2023), 1 descendant of its own
- K260571: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (2026), 0 descendants of its own

## Indications for use
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions: • 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. • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Source page: https://510kreport.com/device/K212903
Methodology: https://510kreport.com/methodology