# K120760: LDR Spine Spinetune TL Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA, Inc.
- Decided: Jun 27, 2012 after 106 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 6 generations back to K000319 (2000). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100575: LDR Spine Usa Spine Tune TL Spine System, Ldr Spine USA (2010)
- K102331: LDR Spine Usa Spinetune TL Spinal System, Ldr Spine USA (2010) Summary page 2.

## Most influential descendants
- 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
- K231443: Mini-OSTEO Pedicle Fixation System (2023), 0 descendants of its own

## Indications for use
The SpineTuneTM TL Spina[ System is a posterior, non-cervical 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 lordosis) * Tumor * Pseudoarthrosis - Failed previous fusion

Source page: https://510kreport.com/device/K120760
Methodology: https://510kreport.com/methodology