# K183430: Modular Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Mar 13, 2019 after 92 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: 18 generations back to K040583 (2004). 383 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 386 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System, Orthofix, Inc. (2017) Summary page 4.
- K151196: Nautilus Spinal System, Life Spine, Inc. (2015) Summary page 4.
- K140457: Nautilus Spinal System, Life Spine, Inc. (2014) Summary page 4.

## Most influential descendants
- K220341: ARx Modular Spinal System (2022), 1 descendant of its own
- K233455: ARx MIS Spinal Screw System (2023), 0 descendants of its own

## Indications for use
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine 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. Pediatric pedicle screw fixation is limited to a posterior approach. When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation 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 (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis. In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System’s 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.

Source page: https://510kreport.com/device/K183430
Methodology: https://510kreport.com/methodology