# K231098: LineSider® Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants, Inc.
- Decided: Aug 7, 2023 after 111 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: 21 generations back to K040583 (2004). 367 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 371 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190360: LineSider™ Spinal System, Integrity Implants, Inc. (2019) Summary page 6.
- K203367: LineSider™ Spinal System, Integrity Implants, Inc. (2020) Summary page 6.

## Most influential descendants
- K232413: Fusion Robotic Navigation System (2023), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 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/K231098
Methodology: https://510kreport.com/methodology