# K254274: ARx® SAI Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Apr 16, 2026 after 107 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 33 generations back to K841189 (1984). 1,241 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241464: ARx® SAI Implant System, Life Spine, Inc. (2024) Summary page 5.
- K141246: Life Spine Sacroiliac Joint Fixation System, Life Spine, Inc. (2015) Summary page 5.
- K233508: iFuse Bedrock Granite® Implant System, SI-BONE, Inc. (2024) Summary page 5.

## 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 compatible pedicle screws with 5.5- or 6.0-mm posterior rods made from either titanium alloys or cobalt chrome, 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 Please refer to the Instructions for Use/Package Insert for additional information on compatible systems.

Source page: https://510kreport.com/device/K254274
Methodology: https://510kreport.com/methodology