# K220025: ARx® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Mar 31, 2022 after 85 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: 23 generations back to K040583 (2004). 664 ancestors in all.
No later device cites it as a predicate yet.
1 of 665 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141222: Nautilus Spinal System and Solstice Oct System, Life Spine, Inc. (2015) Summary page 4.
- K090320: Conquest Spinal System, Life Spine (2009) Summary page 4.
- K171907: Vitality® Spinal Fixation System, Zimmer Biomet Spine, Inc. (2017) Summary page 4.
- K200070: ARx Spinal System, Life Spine, Inc. (2020) Summary page 4.
- K203163: ARx Illiac Spinal Screw System, Life Spine, Inc. (2020) Summary page 4.
- K191575: ARx Spinal System, Life Spine, Inc. (2019) Summary page 4.
- K210549: ARx Spinal System, Life Spine, Inc. (2021) Summary page 4.
- K133214: Blackbird Spinal System, Choicespine, LP (2014) Summary page 4.
- K190751: Connector System, Orthofix, Inc. (2019) Summary page 4.
- K170804: The Solstice OCT System, Life Spine, Inc. (2017) Summary page 4.
- K143249: SOLSTICE OCT System, Life Spine, Inc. (2015) Summary page 4.

## Indications for use
The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. 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 ARXx® 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), (6) spinal stenosis, (7) 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/K220025
Methodology: https://510kreport.com/methodology