510(k) Report

510(k) · Cleared

Cleared

LDR Spine Usa Spinetune TL Spinal System

K102331510(k) SpecialCleared Oct 15, 201059-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ldr Spine USA · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 15, 2010 as substantially equivalent to K100575 (Ldr Spine USA, 2010) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 2000. 6 later devices descend from it.

Decided
Oct 15, 2010
Review
59 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K000319 (2000). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2024: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants clearedK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000K020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalledK091725 · Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) · U&I Corp. · 2009K100575 · LDR Spine Usa Spine Tune TL Spine System · Ldr Spine USA · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K100575 · LDR Spine Usa Spine Tune TL Spine System · Ldr Spine USA · 2010K091725 · Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) · U&I Corp. · 2009K024096 · Optima, Spinal System · U&I Corp., America · 2003 · recalledK020279 · Forex Corporation, Optima, Spinal System · Forex Corp. · 2002 · recalledK000319 · Ebi Xfix DFS System · Ebi, L.P. · 2000−50+5
  1. Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
  2. 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
  3. 3 generations backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
  4. 2 generations backK091725 Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020…U&I Corp. · 2009
  5. 1 generation backK100575 LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA · 2010
  6. This deviceK102331 LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA · 2010
  7. Descendant · cites it directly · 4 of its ownK120760 LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc. · 2012
  8. Descendant · 2 generations on · 3 of its ownK141186 Firebird Spinal Fixation SystemOrthofix, Inc. · 2015
  9. Descendant · 3 generations on · 2 of its ownK201420 Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
  10. Descendant · 4 generations on · 1 of its ownK223096 Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
  11. Descendant · cites it directly · 0 of its ownK243281 LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 12015: 12021: 12023: 22024: 1
2012high 2 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • 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
  • K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K000319Ebi Xfix DFS SystemEbi, L.P.2000—
−4K020279Forex Corporation, Optima, Spinal SystemForex Corp.20024
−3K024096Optima, Spinal SystemU&I Corp., America20033
−2K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp.2009—
−1K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA2010—
0 (this device)K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA2010—
+1K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.2012—
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.2015—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC2021—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC2023—
+1K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
202110
202320
202410
FIG. 1 — Lineage of K102331, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K100575LDR Spine Usa Spine Tune TL Spine System
Summary page 1
…KWP 888.3050 - Orthosis, Spinal Interlaminal Fixation 5. Legally Marketed Equivalent Predicate Device: SpineTune TM Spinal System (Ki100575) OPTIMA T M Spinal System (K024096) 6. Device Description The SpineTune T M TL Spinal System is a top-loadin…
Ldr Spine USA2010—
*K024096Optima, Spinal System
Summary page 1
…hosis, Spinal Interlaminal Fixation 5. Legally Marketed Equivalent Predicate Device: SpineTune TM Spinal System (Ki100575) OPTIMA T M Spinal System (K024096) 6. Device Description The SpineTune T M TL Spinal System is a top-loading multiple fixation system which consi…
U&I Corp., America20033

Also cleared against K100575: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124
K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240

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 9 months on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K120760 (Ldr Spine USA, Inc., 2012) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K100575.

How does its category compare?

All MNI devices

MNI 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

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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 lordosis)

* Tumor

* Pseudoarthrosis

* Failed previous fusion

Indications for use as stated in the FDA summary.

Also cleared against K100575

1 other device cites the same predicate.

  • K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc. · 2012

More from Ldr Spine USA

25 FDA decisions under this applicant name. See the company

  • K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemLdr Spine USA · 20161 recall
  • K152137FacetBRIDGE SystemLdr Spine USA · 2016
  • K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
  • K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA · 2015
  • K110327LDR Spine Roi-a Interbody Fusion SystemLdr Spine USA · 2011

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K102331 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102331: LDR Spine Usa Spinetune TL Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102331

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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