# K241464: ARx® SAI Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jul 29, 2024 after 67 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: 32 generations back to K841189 (1984). 1,240 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 1,242 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 5.
- K203163: ARx Illiac Spinal Screw System, Life Spine, Inc. (2020) Summary page 5.
- K233508: iFuse Bedrock Granite® Implant System, SI-BONE, Inc. (2024) Summary page 5.
- K180749: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2018) Summary page 5.
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2020) Summary page 5.

## Most influential descendants
- K254274: ARx® SAI Implant System (2026), 0 descendants of its own

## Indications for use
The ARx® SAI Implant System is intended for sacroiliac joint fusion for the following conditions: • Sacroiliac joint dysfunction and degenerative sacroiliitis include 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. When connected to Arx® Spinal System, the ARx SAI Implant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: • Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. • Spondylolisthesis • Trauma (i.e., fracture or dislocation) • Spinal Stenosis • Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis) • Spinal tumor • Pseudarthrosis • Failed previous fusion

Source page: https://510kreport.com/device/K241464
Methodology: https://510kreport.com/methodology