510(k) · Cleared
ClearedROI-C Titanium-Coated Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Dec 7, 2015 as substantially equivalent to K113559 (Ldr Spine USA, Inc., 2011) and 2 other predicates after a 146-day review. Its family tree reaches back 13 generations to 1984. 9 later devices descend from it.
- Decided
- Dec 7, 2015
- Review
- 146 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K841189 (1984). 51 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 2 generations backK120819 Stalif CCentinel Spine, Inc. · 2012
- 1 generation backK131951 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2013
- This deviceK151934 ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
- Descendant · cites it directly · 7 of its ownK181621 Stable-C Interbody SystemNexus Spine, LLC · 2018
- Descendant · 2 generations on · 6 of its ownK231763 Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 3 generations on · 5 of its ownK232530 Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023
- Descendant · 4 generations on · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 7 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 6 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 5 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 4 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 3 generations backK102606 Avs Anchor-C Cervical Cage SystemStryker Spine · 2011 · Recalled
- 2 generations backK120819 Stalif CCentinel Spine, Inc. · 2012
- 1 generation backK131951 Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. · 2013
- This deviceK151934 ROI-C Titanium-Coated Implant SystemLdr Spine USA · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181621Stable-C Interbody SystemNexus Spine, LLC · 2018 · cites it directly7descendants
- K231763Stable-C Interbody SystemNexus Spine, LLC · 2023 · 2 generations on6descendants
- K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC · 2023 · 3 generations on5descendants
- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · 4 generations on3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −7 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −6 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −5 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −4 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −3 | K102606 | Avs Anchor-C Cervical Cage System | Stryker Spine | 2011 | 1 |
| −2 | K120819 | Stalif C | Centinel Spine, Inc. | 2012 | — |
| −1 | K131951 | Irix-C Cervical Integrated Fusion System | X-Spine Systems, Inc. | 2013 | — |
| 0 (this device) | K151934 | ROI-C Titanium-Coated Implant System | Ldr Spine USA | 2015 | — |
| +1 | K181621 | Stable-C Interbody System | Nexus Spine, LLC | 2018 | — |
| +2 | K231763 | Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +3 | K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023 | — |
| +4 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 4…Primary Predicate: LDR Spine Cervical Interbody Fusion System – ROI-C Lordotic Implants (K113559) Additional Predicates: X-Spine Irix-C Spinal Implant… | 2011 |
| * | K131951 | Irix-C Cervical Integrated Fusion SystemSummary page 4…OI-C Lordotic Implants (K113559) Additional Predicates: X-Spine Irix-C Spinal Implant System (K131951) Centinel Spine Stalif-C® Ti (K133200) Device Description: The ROI-C Titanium-Coate… | 2013 |
| * | K133200 | Stalif C (R)Summary page 4…ional Predicates: X-Spine Irix-C Spinal Implant System (K131951) Centinel Spine Stalif-C® Ti (K133200) Device Description: The ROI-C Titanium-Coated Implant System consists of ‘D’ shaped blocks in two profiles, anato… | 2014 |
What descends from it? (9)
2 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?
- The line of descent spans 31 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 51 ancestors have a recall of any class.
- Of its descendants, K181621 (Nexus Spine, LLC, 2018) has gone furthest, with 7 descendants of its own.
- 20 other devices also cite its predicate K113559.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The LDR Spine ROI-C Titanium-Coated Implant 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The ROI-C Implant System implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous 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.
https://510kreport.com/device/K151934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151934: ROI-C Titanium-Coated 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/K151934
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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