# K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Sep 18, 2020 after 101 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: 16 generations back to K930834 (1993). 36 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 50 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.
- K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2018) Summary page 4.
- K141549: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 4.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 4.

## Most influential descendants
- 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
- K240505: Eminent Spine SI Screw System (2024), 1 descendant 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/K201538
Methodology: https://510kreport.com/methodology