510(k) · Cleared
ClearedLDR Spine Roi-a Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Sep 30, 2011 as substantially equivalent to K082262 (Ldr Spine USA, 2009) and 1 other predicate after a 239-day review. Its family tree reaches back 1 generation to 2009. 241 later devices descend from it.
- Decided
- Sep 30, 2011
- Review
- 239 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K082262 (2009). 2 ancestors in all. 241 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK082262 LDR Spine Roi Interbody Fusion SystemLdr Spine USA · 2009 · Recalled
- This deviceK110327 LDR Spine Roi-a Interbody Fusion SystemLdr Spine USA · 2011
- Descendant · cites it directly · 199 of its ownK113285 LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc. · 2012
- Descendant · 2 generations on · 191 of its ownK142645 Avenue T TLIF CageLdr Spine USA, Inc. · 2015
- Descendant · cites it directly · 189 of its ownK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- Descendant · 2 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 3 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
Showing 5 of 241 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 241 · See all- K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc. · 2012 · cites it directly199descendants
- K142645Avenue T TLIF CageLdr Spine USA, Inc. · 2015 · 2 generations on191descendants
- K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA · 2016 · cites it directly189descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 2 generations on161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 3 generations on116descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082262 | LDR Spine Roi Interbody Fusion System | Ldr Spine USA | 2009 | 1 |
| 0 (this device) | K110327 | LDR Spine Roi-a Interbody Fusion System | Ldr Spine USA | 2011 | — |
| +1 | K113285 | LDR Spine Usa Avenue L Interbody Fusion | Ldr Spine USA, Inc. | 2012 | — |
| +2 | K142645 | Avenue T TLIF Cage | Ldr Spine USA, Inc. | 2015 | — |
| +1 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| +2 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +3 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 29 | 0 |
| 2024 | 44 | 0 |
| 2025 | 38 | 0 |
| 2026 | 34 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082262 | LDR Spine Roi Interbody Fusion SystemSummary page 1…vertebral Fusion Device with Bone Graft, Lumbar Legally Marketed Predicate Device: LDR Spine ROI Implant System (K082262, K090507) Device Description The ROI- A Oblique implant is intended for use as an interbody… | 2009 |
| * | K090507 | Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant SystemSummary page 1…Fusion Device with Bone Graft, Lumbar Legally Marketed Predicate Device: LDR Spine ROI Implant System (K082262, K090507) Device Description The ROI- A Oblique implant is intended for use as an interbody… | 2009 |
What descends from it? (241)
See all 2415 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?
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110327: LDR Spine Roi-a Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110327
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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