510(k) · Cleared
Recalled · Class II · 2016Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jun 25, 2009 after a 120-day review. The FDA summary names its predicate without a number. 281 later devices descend from it. It has been recalled once.
- Decided
- Jun 25, 2009
- Review
- 120 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 0
281 later devices descend from it, 6 citing it directly.
- This deviceK090507 Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant…Ldr Spine USA · 2009
- Descendant · cites it directly · 241 of its ownK110327 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
Showing 5 of 281 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 281 · See all- K110327LDR Spine Roi-a Interbody Fusion SystemLdr Spine USA · 2011 · cites it directly241descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090507 | Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System | Ldr Spine USA | 2009 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 0 |
| 2020 | 17 | 0 |
| 2021 | 21 | 0 |
| 2022 | 30 | 0 |
| 2023 | 32 | 0 |
| 2024 | 47 | 0 |
| 2025 | 40 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | ROI-A System Named without a submission number |
What descends from it? (281)
See all 2816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110327 | LDR Spine Roi-a Interbody Fusion System | 2011 | 241 |
| K113285 | LDR Spine Usa Avenue L Interbody Fusion | 2012 | 199 |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T… | 2016 | 189 |
| K122639 | Synthes Syncage Evolution Spacer | 2013 | 143 |
| K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal… | 2012 | 16 |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | 2019 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2016 | Class II | Z-0045-2017 | Device Design | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110327 (Ldr Spine USA, 2011) has gone furthest, with 241 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the ROI Interbody Fusion 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 level 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…
Read the full statement (197 words)
When used as an intervertebral body fusion device, the ROI Interbody Fusion 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 level 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.
When used as a vertebral body replacement device, The ROI System of implants 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. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
The implants are intended to be implanted singularly (for ROI-A).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090507
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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