510(k) · Cleared
ClearedLDR Spine Usa Spine Tune TL Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 31, 2010 as substantially equivalent to K091725 (U&I Corp., 2009) after a 30-day review. Its family tree reaches back 4 generations to 2000. 7 later devices descend from it.
- Decided
- Mar 31, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000319 (2000). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK091725 Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020…U&I Corp. · 2009
- This deviceK100575 LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA · 2010
- Descendant · cites it directly · 6 of its ownK102331 LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA · 2010
- Descendant · cites it directly · 4 of its ownK120760 LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK141186 Firebird Spinal Fixation SystemOrthofix, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK223096 Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA · 2010 · cites it directly6descendants
- K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc. · 2012 · cites it directly4descendants
- K141186Firebird Spinal Fixation SystemOrthofix, Inc. · 2015 · 2 generations on3descendants
- K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021 · 3 generations on2descendants
- K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| −1 | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) | U&I Corp. | 2009 | — |
| 0 (this device) | K100575 | LDR Spine Usa Spine Tune TL Spine System | Ldr Spine USA | 2010 | — |
| +1 | K102331 | LDR Spine Usa Spinetune TL Spinal System | Ldr Spine USA | 2010 | — |
| +1 | K120760 | LDR Spine Spinetune TL Spinal System | Ldr Spine USA, Inc. | 2012 | — |
| +2 | K141186 | Firebird Spinal Fixation System | Orthofix, Inc. | 2015 | — |
| +3 | K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2021 | — |
| +4 | K223096 | Dark Star Deformity Pedicle Screw System | Republic Spine, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)Summary page 1…Pedicle Fixation KWP 858.3050 - Orthosis, Spinal Interlaminal Fixation 5. Legally Marketed Equivalent Predicate Device: Perfix Spinal System (K091725) 6. Device Description The Spinetune TL Spinal System is a top-loading posterior spinal fixation system consisting of pedi… | 2009 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K102331 (Ldr Spine USA, 2010) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K091725.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100575: LDR Spine Usa Spine Tune TL Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100575
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026