510(k) Report

510(k) · Cleared

Cleared

Open Radiotransparent Intersomatic Implant (Roi)

K043349510(k) TraditionalCleared Jun 29, 2005205-day reviewClass II21 CFR 888.3060

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

Ldr Spine USA · MQP Spinal Vertebral Body Replacement Device

Cleared on Jun 29, 2005 as substantially equivalent to K042268 (Ebi, L.P., 2004) and 2 other predicates after a 205-day review. Its family tree reaches back 6 generations to 1984. 134 later devices descend from it.

Decided
Jun 29, 2005
Review
205 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K841189 (1984). 14 ancestors in all. 134 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2002: 2 other ancestors2003: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor2007: 2 descendants cleared2008: 2 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2013: 2 descendants cleared2018: 3 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2025: 22 descendants cleared2024: 20 descendants cleared2015: 1 descendant cleared2019: 5 descendants cleared2020: 11 descendants cleared2023: 19 descendants cleared2021: 9 descendants cleared2022: 12 descendants cleared2026: 22 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) K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 9 descendants4 generations forward: 10 descendants5 generations forward: 36 descendants6 generations forward: 34 descendants7 generations forward: 24 descendants8 generations forward: 8 descendants9 generations forward: 3 descendants K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 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. · 1984−50+5
  1. Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 1 generation backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. This deviceK043349 Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA · 2005
  8. Descendant · cites it directly · 113 of its ownK080572 LDR Spine Roi-a ImplantLdr Spine USA · 2008
  9. Descendant · 2 generations on · 112 of its ownK102402 Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · Recalled
  10. Descendant · 3 generations on · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
  11. Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
  12. Descendant · 4 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019

Showing 5 of 134 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22011: 12012: 12013: 22014: 12015: 12017: 12018: 32019: 52020: 112021: 92022: 122023: 192024: 202025: 222026: 22
2007high 22 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 134 · See all
  • K080572LDR Spine Roi-a ImplantLdr Spine USA · 2008 · cites it directly113descendants
  • K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · 2 generations on112descendants
  • K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on110descendants
  • K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
  • K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−5K990148Stackable Cage SystemDepuy Motech Acromed1999—
−4K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−3K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−2K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−1K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
0 (this device)K043349Open Radiotransparent Intersomatic Implant (Roi)Ldr Spine USA2005—
+1K080572LDR Spine Roi-a ImplantLdr Spine USA2008—
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.2019—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200220
200310
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
201110
201210
201320
201410
201510
201710
201830
201950
2020110
202190
2022120
2023190
2024200
2025220
2026220
FIG. 1 — Lineage of K043349, 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 MQP? 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 MQP device

  1. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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? (3)

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
*K042268Ebi Cas Spine Spacer System
Summary page 1
…Equivalent PredicateDevice: LDR Spine USA proposes that the ROI is substantially equivalent to the following: - EBI CAS Spine Spacer System- K042268 - Signus PEEK Tetris"" Spinal Implant - K031757 - Signus Curved PEEK Tetris tm Spinal Implant - K041888…
Ebi, L.P.2004—
*K031757Peek Tetris Spinal Implant
Summary page 1
…oposes that the ROI is substantially equivalent to the following: - EBI CAS Spine Spacer System- K042268 - Signus PEEK Tetris"" Spinal Implant - K031757 - Signus Curved PEEK Tetris tm Spinal Implant - K041888 Equivalence is demonstrated in the design, material…
Signus Medical, LLC2003—
*K041888Curved Peek Tetris Spinal Implant
Summary page 1
…- EBI CAS Spine Spacer System- K042268 - Signus PEEK Tetris"" Spinal Implant - K031757 - Signus Curved PEEK Tetris tm Spinal Implant - K041888 Equivalence is demonstrated in the design, material composition, surgical technique and intended use. 5. Device…
Signus Medizintechnik GmbH2004—

Also cleared against K042268: 7 other devices →

What descends from it? (134)

See all 134

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

NumberDeviceApplicantDecidedDescendants
K080572LDR Spine Roi-a ImplantLdr Spine USA2008113
K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216
K072132LDR Spine Roi-T SystemLdr Spine USA20071
K080569LDR Spine Roi-T ImplantLdr Spine USA20080
K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070

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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K080572 (Ldr Spine USA, 2008) has gone furthest, with 113 descendants of its own.
  • 7 other devices also cite its predicate K042268.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

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

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

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

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, 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
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Indications for use as stated in the FDA summary.

Also cleared against K042268

7 other devices cite the same predicate.

  • K091381Ibex Spinal SystemEbi, L.P. · 2009
  • K071274Gso GS1 SpacerGold Standard Orthopedics, LLC · 2007
  • K052384Lanx VBR SystemLanx, LLC · 2005
  • K043479MC+ Partial VBRLdr Spine USA · 2005
  • K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
  • K042714Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4Spine Next America Corporation · 2004

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 MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K043349 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043349: Open Radiotransparent Intersomatic Implant (Roi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043349

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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