510(k) Report

510(k) · Cleared

Cleared

LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants

K113559510(k) SpecialCleared Dec 29, 201128-day reviewClass II21 CFR 888.3080

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

Ldr Spine USA, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Dec 29, 2011 as substantially equivalent to K091088 (Ldr Spine USA, 2009) after a 28-day review. Its family tree reaches back 10 generations to 1984. 383 later devices descend from it.

Decided
Dec 29, 2011
Review
28 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K841189 (1984). 28 ancestors in all. 383 later devices descend from it, 21 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 4 other ancestors2001: 8 other ancestors2005: 1 other ancestor2004: 3 other ancestors2003: 1 other ancestor2000: 1 other ancestor2016: 5 descendants cleared2015: 9 descendants cleared2014: 3 descendants cleared2012: 3 descendants cleared2018: 18 descendants cleared2013: 2 descendants cleared2017: 11 descendants cleared2026: 49 descendants cleared2023: 61 descendants cleared2021: 29 descendants cleared2024: 51 descendants cleared2019: 21 descendants cleared2025: 55 descendants cleared2020: 28 descendants cleared2022: 38 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008×2: 2 generations cleared close together, K083857 (2009), K091088 (2009) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 7 other ancestors6 generations back: 2 other ancestors 1 generation forward: 21 descendants2 generations forward: 49 descendants3 generations forward: 70 descendants4 generations forward: 81 descendants5 generations forward: 60 descendants6 generations forward: 51 descendants7 generations forward: 32 descendants8 generations forward: 13 descendants9 generations forward: 5 descendants10 generations forward: 1 descendant K091088 · LDR Spine Cervical Interbody Fusion System · Ldr Spine USA · 2009K083857 · LDR Spine Roi-C Implant · Ldr Spine USA · 2009K080728 · LDR Spine Roi-C Implant · Ldr Spine USA · 2008K043479 · MC+ Partial VBR · Ldr Spine USA · 2005K033109 · Ellys and Aurys Vertebral Body Replacements · Scient'X · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  4. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  5. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  6. This deviceK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
  7. Descendant · cites it directly · 206 of its ownK122588 Vusion CS PlusOrtho Development Corp. · 2013
  8. Descendant · 2 generations on · 199 of its ownK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
  9. Descendant · 3 generations on · 159 of its ownK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
  10. Descendant · cites it directly · 152 of its ownK151939 COALITION SpacersGlobus Medical, Inc. · 2016
  11. Descendant · 4 generations on · 141 of its ownK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
  7. 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
  8. 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
  9. 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
  10. 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
  11. This deviceK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011

Showing 5 of 383 descendants. See all descendants

Descendants cleared per year

2012: 32013: 22014: 32015: 92016: 52017: 112018: 182019: 212020: 282021: 292022: 382023: 612024: 512025: 552026: 49
2012high 61 (2023) · low 2 (2013)2026

Most influential descendants

Showing 5 of 383 · See all
  • K122588Vusion CS PlusOrtho Development Corp. · 2013 · cites it directly206descendants
  • K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 2 generations on199descendants
  • K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH · 2017 · 3 generations on159descendants
  • K151939COALITION SpacersGlobus Medical, Inc. · 2016 · cites it directly152descendants
  • K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018 · 4 generations on141descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K033109Ellys and Aurys Vertebral Body ReplacementsScient'X2004—
−4K043479MC+ Partial VBRLdr Spine USA2005—
−3K080728LDR Spine Roi-C ImplantLdr Spine USA2008—
−2K083857LDR Spine Roi-C ImplantLdr Spine USA2009—
−1K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009—
0 (this device)K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011—
+1K122588Vusion CS PlusOrtho Development Corp.2013—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH20172
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT…Eit Emerging Implant Technologies GmbH2017—
+1K151939COALITION SpacersGlobus Medical, Inc.2016—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200180
200240
200310
200430
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201320
201430
201590
201650
2017110
2018180
2019210
2020280
2021290
2022380
2023610
2024510
2025550
2026490
FIG. 1 — Lineage of K113559, 1984–2026Source: 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 ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 1
…m- ROI-C Lordotic Implants Legally Marketed LDR Spine Cervical Interbody Fusion System Predicate Device: K091088 Device Description The ROI-C Lordlotic implant is an extension of the currently…
Ldr Spine USA2009—

Also cleared against K091088: 50 other devices →

What descends from it? (383)

See all 383

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

NumberDeviceApplicantDecidedDescendants
K122588Vusion CS PlusOrtho Development Corp.2013206
K151939COALITION SpacersGlobus Medical, Inc.2016152
K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116
K142940Endoskeleton TCS SystemTitan Spine, LLC2015111
K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108
K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559
K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.201447
K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741
K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629
K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427

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 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
  • 3 of the 28 ancestors have a recall of any class.
  • Of its descendants, K122588 (Ortho Development Corp., 2013) has gone furthest, with 206 descendants of its own.
  • 50 other devices also cite its predicate K091088.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The LDR Spine Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

Indications for use as stated in the FDA summary.

Also cleared against K091088

50 other devices cite the same predicate.

  • K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc. · 2024
  • K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC · 2023
  • K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC · 2023
  • K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC · 2023
  • K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC · 2020
  • K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC · 2020

More from Ldr Spine USA, Inc.

10 FDA decisions under this applicant name. See the company

  • K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc. · 2017
  • K161173Avenue® T TLIF CageLdr Spine USA, Inc. · 2016
  • K161798FacetBRIDGE® SystemLdr Spine USA, Inc. · 2016
  • K142645Avenue T TLIF CageLdr Spine USA, Inc. · 2015
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K113559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113559

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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