# K100575: LDR Spine Usa Spine Tune TL Spine System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Mar 31, 2010 after 30 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 4 generations back to K000319 (2000). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549), U&I Corp. (2009) Summary page 1.

## Most influential descendants
- K102331: LDR Spine Usa Spinetune TL Spinal System (2010), 6 descendants of its own
- K120760: LDR Spine Spinetune TL Spinal System (2012), 4 descendants of its own
- K141186: Firebird Spinal Fixation System (2015), 3 descendants of its own
- K201420: Republic Spine Dark Star Spinal System (2021), 2 descendants of its own
- K223096: Dark Star Deformity Pedicle Screw System (2023), 1 descendant of its own

## Indications for use
The SpineTune' Tm TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: * Spondylolisthesis (Grade 3 and 4) * Degenerative spondylolisthesis with objective evidence of neurological impairment * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis) * Tumor * Pseudloarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K100575
Methodology: https://510kreport.com/methodology