510(k) · Cleared
Recalled · Class II · 2016LDR Spine Roi Interbody Fusion 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 Feb 2, 2009 after a 178-day review. The FDA summary names no predicate by number. 1 of the 723 devices in its family, counting itself, has a Class I recall. 722 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 2009
- Review
- 178 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 0
722 later devices descend from it, 8 citing it directly. 1 of the 723 devices in this family, counting this one, has a Class I recall.
- This deviceK082262 LDR Spine Roi Interbody Fusion SystemLdr Spine USA · 2009
- Descendant · cites it directly · 609 of its ownK092901 Epicage Interbody Fusion DeviceR Tree Innovations · 2010
- Descendant · 2 generations on · 602 of its ownK130548 Epicage Interbody Fusion DeviceAlphatec Spine, Inc. · 2013
- Descendant · 3 generations on · 596 of its ownK132601 Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013
- Descendant · 4 generations on · 590 of its ownK140319 Coroent TI-C SystemNuvasive, Inc. · 2014
- Descendant · 4 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
Showing 5 of 722 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 722 · See all- K092901Epicage Interbody Fusion DeviceR Tree Innovations · 2010 · cites it directly609descendants
- K130548Epicage Interbody Fusion DeviceAlphatec Spine, Inc. · 2013 · 2 generations on602descendants
- K132601Coroent Sterile Implants SystemNu Vasive, Incorporated · 2013 · 3 generations on596descendants
- K140319Coroent TI-C SystemNuvasive, Inc. · 2014 · 4 generations on590descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 4 generations on588descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082262 | LDR Spine Roi Interbody Fusion System | Ldr Spine USA | 2009 | — |
| +1 | K092901 | Epicage Interbody Fusion Device | R Tree Innovations | 2010 | — |
| +2 | K130548 | Epicage Interbody Fusion Device | Alphatec Spine, Inc. | 2013 | — |
| +3 | K132601 | Coroent Sterile Implants System | Nu Vasive, Incorporated | 2013 | — |
| +4 | K140319 | Coroent TI-C System | Nuvasive, Inc. | 2014 | — |
| +4 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 13 | 0 |
| 2016 | 33 | 0 |
| 2017 | 40 | 0 |
| 2018 | 45 | 0 |
| 2019 | 58 | 0 |
| 2020 | 79 | 0 |
| 2021 | 59 | 1 |
| 2022 | 66 | 0 |
| 2023 | 79 | 0 |
| 2024 | 87 | 0 |
| 2025 | 75 | 0 |
| 2026 | 62 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (722)
See all 7228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092901 | Epicage Interbody Fusion Device | 2010 | 609 |
| K101310 | VU Apod Intervertebral Body Fusion Device | 2010 | 480 |
| K100802 | Aesculap Implant Systems Sibd Spinal System | 2010 | 461 |
| 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 |
| K093808 | Incite Innovation Stand Alone Interbody Fusion Device | 2010 | 113 |
| K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal… | 2012 | 16 |
Has anything in its family been recalled? (1 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 |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K092901 (R Tree Innovations, 2010) has gone furthest, with 609 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 (207 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 ROI-A implants are intended to be implanted singularly while the ROI-T implants may be implanted singularly or in pairs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K082262 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082262: LDR Spine Roi Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082262
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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