# K190360: LineSider™ Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants, Inc.
- Decided: Jun 21, 2019 after 126 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: 19 generations back to K040583 (2004). 329 ancestors in all.
13 later devices descend from it; 5 cite it directly.
1 of 343 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170126: NuVasive® Reline® 4.5-5.0 System, Nu Vasive, Incorporated (2017) Summary page 5.
- K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat, Interpore Cross Intl. (2004) Summary page 5.

## Most influential descendants
- K203367: LineSider™ Spinal System (2020), 5 descendants of its own
- K210539: CoreLink Midline Fixation System (2021), 4 descendants of its own
- K231098: LineSider® Spinal System (2023), 3 descendants of its own
- K232413: Fusion Robotic Navigation System (2023), 2 descendants of its own
- K221776: NextGen Pedicle Screw System (2022), 2 descendants of its own

## Indications for use
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K190360
Methodology: https://510kreport.com/methodology