# K191575: ARx Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Aug 8, 2019 after 55 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: 20 generations back to K040583 (2004). 573 ancestors in all.
10 later devices descend from it; 3 cite it directly.
1 of 584 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151196: Nautilus Spinal System, Life Spine, Inc. (2015) Summary page 4.
- K133564: Modification to Nautilus Spinal System, Life Spine, LLC (2014) Summary page 4.
- K182974: NuVasive Reline System, Nu Vasive, Incorporated (2019) Summary page 4.

## Most influential descendants
- K200070: ARx Spinal System (2020), 9 descendants of its own
- K203163: ARx Illiac Spinal Screw System (2020), 5 descendants of its own
- K241464: ARx® SAI Implant System (2024), 1 descendant of its own
- K220341: ARx Modular Spinal System (2022), 1 descendant of its own
- K202836: GX Navigation Instrument System (2021), 1 descendant of its own

## Indications for use
The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (7) spinal stenosis, (8) spondylolisthesis. In order to achieve additional levels of fixation in skeletally mature patients, the ARX Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System’s 3.5mm rod.

Source page: https://510kreport.com/device/K191575
Methodology: https://510kreport.com/methodology