# K203367: LineSider™ Spinal System

- Pathway: 510(k) (Special)
- Applicant: Integrity Implants, Inc.
- Decided: Dec 3, 2020 after 17 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 366 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 372 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 4.
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, Medacta International S.A. (2017) Summary page 5.

## Most influential descendants
- K231098: LineSider® Spinal System (2023), 3 descendants of its own
- 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
- K212088: Integrity Implants Navigated Instruments (2021), 0 descendants of its own

## Recalls of this device
- Aug 3, 2022 · Class II · Z-0421-2023: Potential for intraoperative screw head separation at weld location.
- Jan 27, 2022 · Class II · Z-0420-2023: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
- Jan 27, 2022 · Class II · Z-0418-2023: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
- Jan 27, 2022 · Class II · Z-0419-2023: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

## 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/K203367
Methodology: https://510kreport.com/methodology