# K233455: ARx MIS Spinal Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 12, 2023 after 53 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: 24 generations back to K040583 (2004). 633 ancestors in all.
No later device cites it as a predicate yet.
1 of 634 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203163: ARx Illiac Spinal Screw System, Life Spine, Inc. (2020) Summary page 4.
- K220341: ARx Modular Spinal System, Life Spine, Inc. (2022) Summary page 4.
- K111953: Nautilus Spinal System, Life Spine (2012) Summary page 4.
- K133564: Modification to Nautilus Spinal System, Life Spine, LLC (2014) Summary page 4.
- K140457: Nautilus Spinal System, Life Spine, Inc. (2014) Summary page 4.
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2019) 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 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), (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/K233455
Methodology: https://510kreport.com/methodology